A pilot study to investigate the bioequivalence of two Roflumilast 500 μg tablet formulations (B and E) in healthy volunteers. A single-centre, single-dose, open label, randomized, four-period change-over phase I study with two replicated treatment sequences and a washout interval of at least 7 days between periods

Study identifier:RO-2455/EM-056

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2007-002338-12

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

All

Actual Enrollment

24

Study type

Interventional

Age

45 Years - Years

Date

Study Start Date: 01 Jul 2007
Primary Completion Date: -
Study Completion Date: 01 Oct 2007

Study design

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

Verification:

Verified 01 Jun 2016 by Takeda

Sponsors

Takeda

Collaborators

-

Inclusion and exclusion criteria