Last reviewed · How we verify
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fed Conditions
This is an open label, randomised, 2-way crossover, comparative bioequivalence study.
Details
| Lead sponsor | Dr. Reddy's Laboratories Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 44 |
| Start date | 2006-04 |
| Completion | 2006-04 |
Conditions
- Healthy
Interventions
- Desloratadine and pseudoephedrine
Primary outcomes
- Area under curve(AUC) — Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose
Countries
United States