AZD1981 Midazolam CYP4503A Induction study
Study identifier:D9831C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open, Randomised, Non-comparative, Parallel Group Study of a Potential Cytochrome P450 3A Induction after Repeat Twice Daily Oral Dosing with 100 and 500 mg AZD1981 Tablets for 14 days to Healthy Male Volunteers with Single Oral Doses of Midazolam 7.5 mg.
Medical condition
healthy male volunteer
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1981, Midazolam
Sex
Male
Actual Enrollment
28
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Mar 2009
Primary Completion Date: -
Study Completion Date: 01 Apr 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1981 100mg and Midazolam | Drug: AZD1981 oral tablets during 14 consecutive days. Drug: Midazolam Each subject will receive two single doses of 7.5 mg midazolam given as oral solution. The Midazolam dose will be given on Day 1 and on day 16. |
| Experimental: 2 AZD1981 500mg and Midazolam | Drug: Midazolam Each subject will receive two single doses of 7.5 mg midazolam given as oral solution. The Midazolam dose will be given on Day 1 and on day 16. |
Contacts
Investigators
Principal Investigator
Eva Pettersson
AstraZeneca R&D, Lund, Sweden
