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Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution

NCT05207111 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-04

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers Bioavailability Study

Interventions

DRUG

Revefenacin Inhalation Solution

Revefenacin Inhalation Solution, 175 mcg/3 mL following a single nebulized inhaled 175 mcg (1 x 175 mcg/3 mL) dose administered under fasting conditions.

Sponsors & Collaborators

  • Mylan Pharma UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Andrew Shaw, PhD · Head of Global PKDM Science Oversight

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207111 on ClinicalTrials.gov