Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions
|ClinicalTrials.gov Identifier: NCT00872924|
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 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.
|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 Fasting Conditions|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||September 2008|
sumatriptan succinate 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) of OHM laboratories Inc. (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA).
Drug: sumatriptan 100mg
Active Comparator: 2
IMITREX® 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan)
Drug: sumatriptan 100mg
- Bioequivalence evaluation of Ranbaxy Sumatriptan 100mg tablets under fasting conditions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872924
|Noida,, Uttar Pradesh, India, 201 301|