Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fasted Conditions
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|ClinicalTrials.gov Identifier: NCT01928056|
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : August 23, 2013
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet. Dosing periods were separated by a washout period during fasted study.
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Montelukast Sodium Tablets 10 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium 10 mg Tablet (Test, Torrent Pharmaceuticals Ltd., India) Versus Singulair® (Montelukast Sodium) 10 mg Tablet (Reference, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fasting Condition|
|Actual Primary Completion Date :||December 2009|
- bioequivalence based on Composite of Pharmacokinetics [ Time Frame: plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration ]bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928056
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.|
|Village Bhat, Gandhinagar, Gujarat, India, 382428|