Study identifier:RO-2455-101-EC
ClinicalTrials.gov identifier:NCT01354782
EudraCT identifier:N/A
CTIS identifier:N/A
An open, single centre, single and repeated dose study to investigate the pharmacokinetic profile of roflumilast and roflumilast N-oxide after administration of 500 μg dose of roflumilast in healthy Chinese subjects
Chronic Obstructive Pulmonary Disease
Phase 1
No
Roflumilast
All
32
Interventional
40 Years +
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
-
The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast 500 μg in healthy Chinese subjects.
Location
Location
Beijing, China, 100032
Arms | Assigned Interventions |
---|---|
Experimental: Roflumilast (This is a pharmacokinetic study) | Drug: Roflumilast Period I: single dose of roflumilast 500 μg orally in the morning. Period II: repeated dose of roflumilast 500 μg orally in the morning for 14 days. |
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