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AZD1981 Midazolam CYP4503A Induction Study

NCT00859352 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2009-04-10

No results posted yet for this study

Summary

The primary objective of the study is to investigate if the exposure of midazolam is clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme induction of CYP3A.

Conditions

  • Healthy Male Volunteer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Eva Pettersson · AstraZeneca R&D, Lund, Sweden

  • Aslak Rautio · Quintiles Hermelinen AB, Luleå, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Completion
2009-04-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859352 on ClinicalTrials.gov