At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
12.5 mg Androxal Formulation A +3 moredrug
Likely dose
12.5 mg Androxal Formulation Afrom record
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A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal
In Brief
A Phase 1 clinical trial evaluating 12.5 mg Androxal Formulation A, 12.5 mg Androxal Formulation B, and 2 other interventions for Bioequivalence. Completed, enrolled 16 participants across 1 site.
Detailed Summary
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartDec 2013
Primary CompletionDec 2013
TodayJul 2026
First PostedNov 14, 2013
Enrollment StartDec 31, 2013
Primary CompletionDec 31, 2013
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 12.6 years ago
Interventions
12.5 mg Androxal Formulation Adrug
Single dose of 12.5 mg Androxal formulation A
12.5 mg Androxal Formulation Bdrug
Single dose of 12.5 mg Androxal Formulation B
25 mg Androxal Formulation Adrug
Single dose of 25 mg Androxal formulation A
25 mg Androxal Formulation Bdrug
Single dose of 25 mg Androxal formulation B