A Drug-Drug Interaction study between AZD1981 and Pravastatin to study the effect of AZD1981 on the kinetics of pravastatin

Study identifier:D9830C00016

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-023876-14

CTIS identifier:N/A

Study Complete

Official Title

A phase I, open label, randomised, parallel group study of repeated oral doses of AZD1981 (100 mg twice daily and 400 mg twice daily via tablet) for eight days and single doses of pravastatin (Pravachol® tablet 40 mg) to evaluate the pharmacokinetic interaction of AZD1981 and pravastatin in healthy male volunteers

Medical condition

Drug interaction

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD1981, pravastatin

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Feb 2011

Primary Completion Date: 01 Apr 2011

Study Completion Date: 01 Apr 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Uppsala, Sweden

Arms	Assigned Interventions
Experimental: A	Drug: AZD1981 100 mg per oral, twice daily for 8 days Drug: pravastatin 40 mg, once daily at Day 1, period A and Day 8, period B Other Name: pravachol
Experimental: B	Drug: AZD1981 4x100 mg per oral, twice daily for 8 days Drug: pravastatin 40 mg, once daily at Day 1, period A and Day 8, period B Other Name: pravachol

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=719&filename=CSR-D9830C00016.pdf
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CSR-D9830C00016.pdf
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

001-800-236-9933

information.center@astrazeneca.com