Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions
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|ClinicalTrials.gov Identifier: NCT00872274|
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : March 31, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: sumatriptan 100mg||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||September 2008|
sumatriptan succinate tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg of sumatriptan) manufactured by OHM Laboratories In
Drug: sumatriptan 100mg
Active Comparator: 2
IMITREX® 100 mg tablets (containing sumatriptan succinate equivalent to 100 mg of sumatriptan)
Drug: sumatriptan 100mg
- Bioequivalence evaluation of Ranbaxy Sumatriptan 100mg tablets under fed conditions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872274
|Noida,, Uttar Pradesh, India, 201 301|