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
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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|
- Bioequivalence evaluation of Ranbaxy Sumatriptan 100mg tablets under fasting conditions [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||September 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872924
|Noida,, Uttar Pradesh, India, 201 301|