NCT00872924

Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions

An Open Label, Bioequivalence Study of Sumatriptan Succinate 100 mg Tablets (Containing 140 mg of Sumatriptan Succinate Equivalent to 100 mg Sumatriptan) Under Fasting 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

An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions

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 sumatriptan) manufactured by OHM Laboratories Inc. with IMITREX® tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg sumatriptan) manufactured by GlaxoSmithkline Research Triangle Park, NC 27709, Made in Canada in healthy, adult, male, human subjects under fasting condition. Following an overnight fast of at least 10 hour, a single oral dose of sumatriptan succinate tablets 100 mg (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) 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 low light condition and supervision of trained study personnel. 32 subjects were enrolled into the study. However, twenty seven (27) subjects completed both the periods of the study. Pharmacokinetic and Statistical analysis was performed on twenty seven subjects (27) subjects.

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