NCT00872274

Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	sumatriptan 100mg

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2009-03-31
• Last updated: 2009-03-31

Locations

1 site across 1 country: India