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Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males

Drug-drug Interaction Clinical Trial

Official title:
AN OPEN-LABEL, MULTIPLE DOSE STUDY TO ASSESS THE DRUG-DRUG INTERACTIONS OF ANDROXAL WITH CYTOCHROME P450 ISOENZYMES IN HEALTHY MALE SUBJECTS

Clinical Trial Summary

The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and tolerability of Androxal will be determined in healthy male subjects administered Androxal 25 mg daily for 3 days.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01991327
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 1
Start date May 2014
Completion date July 2014
View Details
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