Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2013-12-31
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations
NCT02660840
Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
NCT02230046
Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects
NCT01396590
A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fed Conditions
NCT00864890
Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects
NCT06168929
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
12.5 mg Androxal (formulations A and B)
12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
12.5 mg Androxal Formulation A
Single dose of 12.5 mg Androxal formulation A
12.5 mg Androxal Formulation B
Single dose of 12.5 mg Androxal Formulation B
25 mg Androxal (formulations A and B)
25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
25 mg Androxal Formulation A
Single dose of 25 mg Androxal formulation A
25 mg Androxal Formulation B
Single dose of 25 mg Androxal formulation B
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
12.5 mg Androxal Formulation A
Single dose of 12.5 mg Androxal formulation A
12.5 mg Androxal Formulation B
Single dose of 12.5 mg Androxal Formulation B
25 mg Androxal Formulation A
Single dose of 25 mg Androxal formulation A
25 mg Androxal Formulation B
Single dose of 25 mg Androxal formulation B
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male, between the ages of 18-60 years;
* No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
* Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
* Subject is willing to remain in the clinic overnight for the Day 1 and Day 6 visits;
* Must be able to swallow gelatin capsules
Exclusion Criteria
* Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
* Subject with a significant organ abnormality or disease as determined by the Investigator;
* Any medical condition that would interfere with the study as determined by the Investigator;
* Slow Cytochrome P4502D6 (CYP2D6) metabolizer
* Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
* An acute illness within 5 days of study medication administration;;
* A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
* History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
* History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of (corrected QT) QTc interval prolongation;
* An employee or family member of an employee of the study site or the Sponsor.
18 Years
60 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Repros Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anna Chan
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Pharmacology of miami
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor Corporate Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZA-110
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.