Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Ranbaxy Laboratories Limited |
---|---|
Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00872274 |
To access the single-dose oral bioequivalence of sumatriptan succinate 100 mg tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceutical Inc. USA) with IMITREX® 100 mg tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of GlaxoSmithKline in healthy, adult, male, human subjects under fed condition.
Condition | Intervention |
---|---|
Healthy |
Drug: sumatriptan 100mg |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open Label, Bioequivalence Study of Sumatriptan Succinate 100 mg Tablets (Containing 140 mg of Sumatriptan Succinate Equivalent to 100 mg Sumatriptan) Under Fed Conditions |
Enrollment: | 32 |
Study Start Date: | July 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
sumatriptan succinate tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg of sumatriptan) manufactured by OHM Laboratories In
|
Drug: sumatriptan 100mg |
2: Active Comparator
IMITREX® 100 mg tablets (containing sumatriptan succinate equivalent to 100 mg of sumatriptan)
|
Drug: sumatriptan 100mg |
The study was conducted as an open label, balanced, randomized two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing sumatriptan succinate tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg of sumatriptan) manufactured by OHM Laboratories Inc. with IMITREX® 100 mg tablets (containing sumatriptan succinate equivalent to 100 mg of sumatriptan) manufactured by GlaxoSmithKline Research Triangle Park NC 27709, Made in Canada in healthy, adult, male, human, subjects under fed conditions. Following an overnight fast of at least 10 hour, a single oral dose of sumatriptan succinate tablets 100 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under supervision of trained study personnel 30 min after start of a high fat high calorie breakfast.
Thirty-two 32 subjects were enrolled into the study. Twenty-four (24) subjects completed both the periods of the study. Pharmacokinetic and statistical analyses were performed on data from 24 subjects who completed both the periods of the study.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 220_SUMAT_08 |
Study First Received: | March 27, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00872274 History of Changes |
Health Authority: | India: Drugs Controller General of India |
Bioequivalence |
Serotonin Agonists Sumatriptan Neurotransmitter Agents Malnutrition |
Vasoconstrictor Agents Cardiovascular Agents Healthy Serotonin |
Serotonin Agonists Sumatriptan Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Physiological Effects of Drugs Vasoconstrictor Agents Cardiovascular Agents Pharmacologic Actions |