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Clinical trial

An Open Label, Randomized, Two-Period, Two-Treatment, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium Chewable Tablets 5mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Singulair® (Montelukast Sodium) Chewable Tablets 5mg [Reference Formulation, Merck & Co., Inc. USA] in Healthy Human Volunteers Under Fasting Conditions.

NCT01931501 is registered in ClinicalTrials.gov with Torrent Pharmaceuticals Limited as lead sponsor.

NCT NCT01931501
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open Label, Randomized, Two-Period, Two-Treatment, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium Chewable Tablets 5mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Singulair® (Montelukast Sodium) Chewable Tablets 5mg [Reference Formulation, Merck & Co., Inc. USA] in Healthy Human Volunteers Under Fasting Conditions.
Lead sponsor
Torrent Pharmaceuticals Limited
Phase
Phase 1
Overall status
Completed
Start date
Not reported
Completion date
Not reported
Enrollment
Not reported
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy