Pharmacokinetic and clinical safety interaction study between roflumilast 500 μg repeated dose and midazolam (single dose, i.v. 1 mg, oral 2 mg alone and with roflumilast) in healthy male subjects; open, randomized, five periods cross-over study with interspersed fixed treatment periods

Study identifier:BY217/CP-061

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

18

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Mar 2004
Primary Completion Date: -
Study Completion Date: 01 May 2004

Study design

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

Verification:

Verified 01 Jun 2016 by Takeda

Sponsors

Takeda

Collaborators

-

Inclusion and exclusion criteria