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A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00944671
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heartburn
Interventions Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet
Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water
Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
Enrollment 24
Recruitment Details The study was conducted at a single clinical research center in the US. Subjects were recruited via print advertisements and existing patient research files.
Pre-assignment Details Prior to the first treatment period, Health Insurance Portability and Accountability Act (HIPAA) and informed consent were signed. For each subject a medical history was taken, physical examination and laboratory safety tests were conducted. No enrolled subjects were excluded from the trial before randomization.
Arm/Group Title Famotidine With Water/EZ Chew Without Water/EZ Chew With Water EZ Chew Without Water/EZ Chew With Water/Famotidine With Water EZ Chew With Water/Famotidine With Water/EZ Chew Without Water Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water EZ Chew Without Water/Famotidine With Water/EZ Chew With Water EZ Chew With Water/EZ Chew Without Water/Famotidine With Water
Hide Arm/Group Description Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
Period Title: Period I
Started 4 4 4 4 4 4
Completed 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0
Period Title: Period II
Started 4 4 4 4 4 4
Completed 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0
Period Title: Period III
Started 4 4 4 4 4 4
Completed 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0
Arm/Group Title Famotidine With Water/EZ Chew Without Water/EZ Chew With Water EZ Chew Without Water/EZ Chew With Water/Famotidine With Water EZ Chew With Water/Famotidine With Water/EZ Chew Without Water Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water EZ Chew Without Water/Famotidine With Water/EZ Chew With Water EZ Chew With Water/EZ Chew Without Water/Famotidine With Water Total
Hide Arm/Group Description Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 4 4 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
29.8
(20 to 38)
30.0
(20 to 45)
29.8
(22 to 38)
26.3
(22 to 38)
30.8
(19 to 40)
25.0
(20 to 39)
28.6
(19 to 45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
Female
2
  50.0%
3
  75.0%
3
  75.0%
1
  25.0%
2
  50.0%
1
  25.0%
12
  50.0%
Male
2
  50.0%
1
  25.0%
1
  25.0%
3
  75.0%
2
  50.0%
3
  75.0%
12
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
Black 1 1 2 1 2 2 9
Caucasian 3 3 2 2 2 2 14
Native American 0 0 0 1 0 0 1
Weight  
Mean (Full Range)
Unit of measure:  Pounds
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
164.1
(151.5 to 186.1)
152.2
(137.6 to 182.2)
160.4
(148.5 to 175.2)
164.8
(148.5 to 175.2)
168.8
(132.7 to 200.0)
165.3
(134.6 to 206.9)
162.6
(132.7 to 206.9)
1.Primary Outcome
Title Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Hide Description [Not Specified]
Time Frame Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Famotidine/Antacid Combination EZ Chew Tablet Without Water Famotidine/Antacid Combination Tablet With Water
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng*hr/mL
261.2
(227.9 to 299.3)
248.0
(216.4 to 284.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine/Antacid Combination EZ Chew Tablet Without Water, Famotidine/Antacid Combination Tablet With Water
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Given a 3-period crossover design, assuming a true within subject variance for natural log AUC of 0.029, 24 subjects completing the study, and alpha = 0.05, there is a 0.995 probability that the 90% confidence interval for the true geometric mean ratio of AUC for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.05
Confidence Interval 90%
0.98 to 1.13
Estimation Comments [Not Specified]
2.Primary Outcome
Title Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Hide Description [Not Specified]
Time Frame Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Famotidine/Antacid Combination EZ Chew Tablet Without Water Famotidine/Antacid Combination Tablet With Water
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
45.5
(39.1 to 52.9)
44.4
(38.1 to 51.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine/Antacid Combination EZ Chew Tablet Without Water, Famotidine/Antacid Combination Tablet With Water
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a true within subject variance for natural log Cmax of 0.017, there is a 0.999 probability that the 90% confidence interval for the true geometric mean ratio of Cmax for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.03
Confidence Interval 90%
0.93 to 1.13
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Hide Description [Not Specified]
Time Frame Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Famotidine/Antacid Combination EZ Chew Tablet With Water Famotidine/Antacid Combination Tablet With Water
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng*h/mL
260.1
(227.0 to 298.0)
248.0
(216.4 to 284.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine/Antacid Combination EZ Chew Tablet With Water, Famotidine/Antacid Combination Tablet With Water
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.05
Confidence Interval 90%
0.98 to 1.13
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Hide Description [Not Specified]
Time Frame Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Famotidine/Antacid Combination EZ Chew Tablet With Water Famotidine/Antacid Combination Tablet With Water
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
45.9
(39.4 to 53.4)
44.4
(38.1 to 51.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine/Antacid Combination EZ Chew Tablet With Water, Famotidine/Antacid Combination Tablet With Water
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.03
Confidence Interval 90%
0.93 to 1.14
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Famotidine/Antacid Combination Tablet With Water Famotidine/Antacid Combination EZ Chew Tablet Without Water Famotidine/Antacid Combination EZ Chew Tablet With Water
Hide Arm/Group Description Famotidine/antacid combination tablet with 120 mL of water Famotidine/antacid combination EZ Chew tablet without water Famotidine/antacid combination EZ Chew tablet with 120 mL of water
All-Cause Mortality
Famotidine/Antacid Combination Tablet With Water Famotidine/Antacid Combination EZ Chew Tablet Without Water Famotidine/Antacid Combination EZ Chew Tablet With Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Famotidine/Antacid Combination Tablet With Water Famotidine/Antacid Combination EZ Chew Tablet Without Water Famotidine/Antacid Combination EZ Chew Tablet With Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Famotidine/Antacid Combination Tablet With Water Famotidine/Antacid Combination EZ Chew Tablet Without Water Famotidine/Antacid Combination EZ Chew Tablet With Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/24 (12.50%)      4/24 (16.67%)      5/24 (20.83%)    
Gastrointestinal disorders       
Flatulence * 1  1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Stomach discomfort * 1  0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Nervous system disorders       
Headache * 1  1/24 (4.17%)  1 2/24 (8.33%)  2 4/24 (16.67%)  4
Reproductive system and breast disorders       
Dysmenorrhea * 1  1/24 (4.17%)  1 1/24 (4.17%)  1 0/24 (0.00%)  0
Vascular disorders       
Syncope vasovagal * 1  0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00944671     History of Changes
Other Study ID Numbers: 0208C-145
2009_622
First Submitted: July 22, 2009
First Posted: July 23, 2009
Results First Submitted: October 27, 2014
Results First Posted: June 24, 2015
Last Update Posted: June 24, 2015