Overview

Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution

Status:
Completed
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
Summary
Single-Dose Fasting Bioavailability Study of Revefenacin Inhalation Solution, 175 mcg/3 mL in 24 Healthy Chinese Adult Male and Female Volunteers. This study will evaluate the safety and tolerability of Revefenacin Inhalation Solution in the Chinese population. For the determination of the pharmacokinetic disposition of the formulations, The bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL will be assessed through various pharmacokinetic parameters derived from the plasma concentration-time curves of revefenacin and its active metabolite, THRX-195518.
Phase:
Phase 1
Details
Lead Sponsor:
Mylan Inc.
Collaborator:
Mylan Pharmaceuticals