Trials / Completed

CompletedNCT03075267

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

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

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 96 (actual)

Sponsor: Pearl Therapeutics, Inc. · Industry
Sex: All
Age: 18 Years – 45 Years
Healthy volunteers: Accepted

Summary

A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects

Detailed description

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 Administration and After Chronic Administration for 7 Days

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	PT010 (BGF MDI) 320/14.4/9.6 µg	A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
DRUG	PT010 (BGF MDI) 160/14.4/9.6 µg	A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
DRUG	PT003 (GFF MDI) 14.4/9.6 µg	A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.

Timeline

Start date: 2017-04-17
Primary completion: 2017-09-05
Completion: 2017-09-05
First posted: 2017-03-09
Last updated: 2021-01-19
Results posted: 2021-01-19

Locations

1 site across 1 country: China

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03075267. Inclusion in this directory is not an endorsement.