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Comparison of Two Formulations of Androxal

NCT01984398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-05-06

Study results available
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Summary

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

Conditions

  • Bioequivalence

Interventions

DRUG

12.5 mg Androxal Formulation A

Single dose of 12.5 mg Androxal formulation A

DRUG

12.5 mg Androxal Formulation B

Single dose of 12.5 mg Androxal Formulation B

DRUG

25 mg Androxal Formulation A

Single dose of 25 mg Androxal formulation A

DRUG

25 mg Androxal Formulation B

Single dose of 25 mg Androxal formulation B

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Anna Chan · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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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 NCT01984398 on ClinicalTrials.gov