drugset / Trial / NCT05207111

Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution

NCT05207111

Phase 1 Completed 24 enrolled Mylan Pharma UK Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-09-23
Primary completion
2021-09-30
Completion
2021-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Revefenacin Small molecule 175 ug

Indications

No indication recorded.