Trials / Completed
CompletedNCT01659892
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fed Conditions
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Montelukast | 5 mg Chewable Tablet |
| DRUG | Singulair | 5 mg Chewable Tablet |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2012-08-08
- Last updated
- 2018-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01659892. Inclusion in this directory is not an endorsement.