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Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01138826
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Sponsor:
Collaborators:
Aurobindo Pharma Ltd
Trident Life Sciences Ltd.
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Amlodipine - reference
Drug: Amlodipine ODT - test
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet
Hide Arm/Group Description Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period. Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period. Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period. Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period. Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period. Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
Period Title: First Intervention Period
Started 3 3 3 3 3 3
Completed 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0
Period Title: Washout Period I (of 16 Days)
Started 3 3 3 3 3 3
Completed 2 2 3 3 2 3
Not Completed 1 1 0 0 1 0
Reason Not Completed
Lost to Follow-up             1             1             0             0             1             0
Period Title: Second Intervention Period
Started 2 2 3 3 2 3
Completed 2 2 3 3 2 3
Not Completed 0 0 0 0 0 0
Period Title: Washout Period II (of 16 Days)
Started 2 2 3 3 2 3
Completed 2 2 3 3 2 3
Not Completed 0 0 0 0 0 0
Period Title: Third Intervention Period
Started 2 2 3 3 2 3
Completed 2 2 3 3 2 3
Not Completed 0 0 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
27.22  (7.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
1.Primary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Hide Description AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Hide Arm/Group Description:
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Overall Number of Participants Analyzed 17 15 16
Geometric Mean (Full Range)
Unit of Measure: hr*ng/mL
307.225
(61.736 to 468.617)
324.324
(48.000 to 554.452)
330.411
(54.526 to 687.254)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10mg Tablet With Water (Reference Product A), Amlodipine 10 mg ODT With Water (Test Product B)
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUC[0- ∞] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 105.57
Confidence Interval (2-Sided) 90%
98.09 to 113.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Amlodipine 10mg Tablet With Water (Reference Product A), Amlodipine 10 mg ODT Without Water (Test Product C)
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUC[0- ∞] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 107.55
Confidence Interval (2-Sided) 90%
99.98 to 115.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg ODT With Water (Test Product B), Amlodipine 10 mg ODT Without Water (Test Product C)
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUC[0- ∞] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 101.88
Confidence Interval (2-Sided) 90%
94.70 to 109.60
Estimation Comments [Not Specified]
2.Primary Outcome
Title AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Hide Arm/Group Description:
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Overall Number of Participants Analyzed 17 15 16
Geometric Mean (Full Range)
Unit of Measure: hr*ng/mL
275.302
(60.422 to 439.855)
285.974
(46.480 to 439.395)
287.035
(52.378 to 482.589)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10mg Tablet With Water (Reference Product A), Amlodipine 10 mg ODT With Water (Test Product B)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 103.88
Confidence Interval (2-Sided) 90%
97.27 to 110.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Amlodipine 10mg Tablet With Water (Reference Product A), Amlodipine 10 mg ODT Without Water (Test Product C)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 104.26
Confidence Interval (2-Sided) 90%
97.67 to 111.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg ODT With Water (Test Product B), Amlodipine 10 mg ODT Without Water (Test Product C)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 100.37
Confidence Interval (2-Sided) 90%
94.02 to 107.15
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Hide Arm/Group Description:
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Overall Number of Participants Analyzed 17 15 16
Geometric Mean (Full Range)
Unit of Measure: ng/mL
5.201
(1.880 to 9.350)
5.117
(1.410 to 7.400)
4.952
(1.500 to 7.020)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10mg Tablet With Water (Reference Product A), Amlodipine 10 mg ODT With Water (Test Product B)
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 98.39
Confidence Interval (2-Sided) 90%
91.05 to 106.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Amlodipine 10mg Tablet With Water (Reference Product A), Amlodipine 10 mg ODT Without Water (Test Product C)
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 95.22
Confidence Interval (2-Sided) 90%
88.16 to 102.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg ODT With Water (Test Product B), Amlodipine 10 mg ODT Without Water (Test Product C)
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Method of Estimation Estimation Parameter Adjusted ratio of geometric means
Estimated Value 96.77
Confidence Interval (2-Sided) 90%
89.58 to 104.54
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Hide Arm/Group Description:
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Overall Number of Participants Analyzed 17 15 16
Median (Full Range)
Unit of Measure: hr
8.00
(6.00 to 16.00)
10.00
(6.00 to 16.00)
13.00
(6.00 to 14.00)
5.Secondary Outcome
Title Plasma Decay Half-Life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Hide Arm/Group Description:
Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
Overall Number of Participants Analyzed 17 15 16
Mean (Standard Deviation)
Unit of Measure: hr
44.004  (13.759) 46.698  (14.739) 49.869  (19.638)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Hide Arm/Group Description Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period. Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period. Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
All-Cause Mortality
Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amlodipine 10mg Tablet With Water (Reference Product A) Amlodipine 10 mg ODT With Water (Test Product B) Amlodipine 10 mg ODT Without Water (Test Product C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01138826    
Other Study ID Numbers: A0531095
051-10
First Submitted: March 8, 2010
First Posted: June 7, 2010
Results First Submitted: June 21, 2011
Results First Posted: July 20, 2011
Last Update Posted: July 20, 2011