Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

Study identifier:PT010010

ClinicalTrials.gov identifier:NCT03075267

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

PT010 (BGF MDI) 320/14.4/9.6 µg, PT010 (BGF MDI) 160/14.4/9.6 µg, PT003 (GFF MDI) 14.4/9.6 µg

Sex

All

Actual enrollment

96

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 17 Apr 2017
Primary Completion Date: 05 Sept 2017
Study Completion Date: 05 Sept 2017

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2020 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria