Pharmacokinetics of roflumilast and roflumilast N-oxide after single and repeated oral administration of 250 μg and 500 μg roflumilast in Japanese and Caucasian subjects – a double blind, randomized, dose escalating, two-period, two parallel group comparison

Study identifier:BY217/CP-048

ClinicalTrials.gov identifier:N/A

EudraCT identifier:

CTIS identifier:N/A

Study Complete

Official Title

*Please Note* The Study you are attempting to view was acquired from Takeda by AstraZeneca and was disclosed initially by Takeda per their Transparency Policies. More information regarding this study may be available by contacting [email protected].

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

-

Sex

Male

Actual Enrollment

30

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Aug 2003
Primary Completion Date: -
Study Completion Date: 01 Nov 2003

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jun 2016 by Takeda

Sponsors

Takeda

Collaborators

-

Inclusion and exclusion criteria