PK Study of PT003 and PT001 in Japanese Healthy Subjects

Study identifier:PT003010-00

ClinicalTrials.gov identifier:NCT02196714

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects

Medical condition

COPD

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Glycopyrronium and Formoterol Fumarate (GFF) Dose 1, Glycopyrronium and Formoterol Fumarate (GFF) Dose 2, Glycopyrronium (GP) Dose 1, Glycopyrronium (GP) Dose 2

Sex

All

Actual Enrollment

24

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Jul 2014
Primary Completion Date: 01 Sept 2014
Study Completion Date: -

Study design

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

Verification:

Verified 01 Apr 2019 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria