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Clinical trial

An Open-label Balanced, Randomised, Single Dose, Two-way Crossover Study to Determine the Bioequivalence of GW483100 10 mg Tablets (Containing Montelukast Sodium Equivalent to 10 mg of Montelukast) Relative to Reference Montelukast Sodium 10 mg Tablets (Containing Montelukast Sodium Equivalent to 10 mg of Montelukast) in Healthy Male and Female Volunteers Under Fasting Conditions

NCT02658422 is registered in ClinicalTrials.gov with GlaxoSmithKline as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-label Balanced, Randomised, Single Dose, Two-way Crossover Study to Determine the Bioequivalence of GW483100 10 mg Tablets (Containing Montelukast Sodium Equivalent to 10 mg of Montelukast) Relative to Reference Montelukast Sodium 10 mg Tablets (Containing Montelukast Sodium Equivalent to 10 mg of Montelukast) in Healthy Male and Female Volunteers Under Fasting Conditions
Lead sponsor
GlaxoSmithKline
Phase
Phase 1
Overall status
Completed
Start date
August 18, 2015
Completion date
September 21, 2015
Enrollment
32 (actual)
Sites
1

Conditions

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

asthma and rhinitis, respiratory disorders