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A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.

Healthy Volunteer Clinical Trial

Official title:
A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE BITOPERTIN ON SINGLE DOSE PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY VOLUNTEERS

Clinical Trial Summary

This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers.

A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast.

Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02019290
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Withdrawn
Phase Phase 1
Start date February 10, 2014
Completion date March 31, 2014
View Details
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