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Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water
The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.
Details
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2009-04 |
| Completion | 2009-04 |
Conditions
- Healthy Volunteers
Interventions
- Commercial tablet with water
- ODT #1 without water
- ODT #2 without water
- ODT #1 with water
- ODT #2 with water
Primary outcomes
- Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax) — 24 hr
Countries
Singapore