Overview

A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Montelukast fromAsmakast10 mg tablets (Man. by Minapharm Egypt for Novartis Pharma Egypt S.A.E (Sandoz), Egypt) and Singulair10 mg tablets (Produced by Global Napi Pharmaceuticals, Egypt under license from: Merck & Co. Inc., USA) after a single oral dose administration of each to healthy adults under fasting conditions.
Phase:
Phase 1
Details
Lead Sponsor:
Genuine Research Center, Egypt
Collaborator:
Sandoz
Treatments:
Montelukast