Trial · Interventional
CompletedPhase 1Registry dataStudy to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 12 participants (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Design
- Open label (no masking)
- Countries
- Not stated
- Start
- Jun 2014
- Primary completion
- Jul 2014
- Completion
- Jul 2014
- First posted
- 23 May 2014 (estimated)
- Last update posted
- 11 Aug 2014 (estimated)
- Conditions
- Normal Volunteers
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal
NCT02146391Jun 2014 to Jul 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.
Interventions
- Androxal 25 mg CapsulesDrug
Arms1
Experimental
Androxal 25 mg
Primary outcomes1
Outcomes the sponsor listed as primary.
• Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.
Time frame · 24 hour
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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