Healthy Volunteers Bioavailability Study Clinical Trial
Official title:
Single-Dose Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution, 175 mcg/3 mL in Healthy Chinese Adult Male and Female Volunteers
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.
A single-dose, open-labeled, one-period, one-treatment study to investigate the bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL following administration of a single, nebulized, inhaled 175 mcg (1 x 175 mcg/3mL) dose in a total of 24 healthy, Chinese, adult male and female volunteers under fasting conditions. In addition, this study will evaluate the safety and tolerability of Revefenacin Inhalation Solution in the Chinese population. Ten milliliter (1 × 10 mL) blood samples will be collected at pre-dose and the following times after the initiation of dosing: 5, 10, 15, 30, and 45 minutes along with 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours. The bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL will be assessed through various pharmacokinetic parameters (such as AUC0-t, AUC0-∞, Cmax, and Tmax) derived from the plasma concentration-time curves of revefenacin and its active metabolite, THRX-195518. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02238782 -
A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.
|
Phase 1 |