Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study.
NCT01899638 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-06-07
Summary
This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
UMEC/VI 125/25 mcg
Combination in high dose
- DRUG
-
UMEC/VI 62.5/25 mcg
Combination in low dose
- DRUG
-
UMEC 125 mcg
LAMA mono in high dose
- DRUG
-
UMEC 62.5 mcg
LAMA mono in low dose
- DRUG
-
VI 25 mcg
LABA mono
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-05-20
- Primary Completion
- 2013-07-25
- Completion
- 2013-07-25
Countries
- China
Study Locations
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