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Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00847405
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : August 18, 2009
Last Update Posted : September 11, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Sumatriptan Succinate
Drug: Imitrex®
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test (Sumatriptan) First Reference (Imitrex®) First
Hide Arm/Group Description 100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period. 100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
Period Title: First Intervention
Started 14 14
Completed 14 13
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Washout of 7 Days
Started 14 13
Completed 13 13
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Second Intervention
Started 13 13
Completed 13 13
Not Completed 0 0
Arm/Group Title Test (Sumatriptan) First Reference (Imitrex®) First Total
Hide Arm/Group Description 100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period. 100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period. Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
6
  42.9%
13
  46.4%
Male
7
  50.0%
8
  57.1%
15
  53.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Asian 1 2 3
Black 2 2 4
White 11 10 21
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Hide Description Bioequivalence based on Cmax.
Time Frame Blood samples collected over a 12 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Test (Sumatriptan) Reference (Imitrex®)
Hide Arm/Group Description:
100 mg Sumatriptan Tablets test product dosed in either period.
100 mg Imitrex® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
57.26  (14.45) 56.66  (20.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test (Sumatriptan), Reference (Imitrex®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 103.64
Confidence Interval 90%
95.93 to 111.97
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
2.Primary Outcome
Title AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Hide Description Bioequivalence based on AUC0-t.
Time Frame Blood samples collected over a 12 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Test (Sumatriptan) Reference (Imitrex®)
Hide Arm/Group Description:
100 mg Sumatriptan Tablets test product dosed in either period.
100 mg Imitrex® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
258.76  (76.55) 252.26  (75.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test (Sumatriptan), Reference (Imitrex®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 102.81
Confidence Interval 90%
97.95 to 107.91
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
3.Primary Outcome
Title AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Hide Description Bioequivalence based on AUC0-inf.
Time Frame Blood samples collected over a 12 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Test (Sumatriptan) Reference (Imitrex®)
Hide Arm/Group Description:
100 mg Sumatriptan Tablets test product dosed in either period.
100 mg Imitrex® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
268.5  (79.84) 260.47  (78.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test (Sumatriptan), Reference (Imitrex®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 103.25
Confidence Interval 90%
98.35 to 108.41
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
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.
The Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Name/Title: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals, USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT00847405     History of Changes
Other Study ID Numbers: 2678
First Submitted: February 17, 2009
First Posted: February 19, 2009
Results First Submitted: July 6, 2009
Results First Posted: August 18, 2009
Last Update Posted: September 11, 2009