Oxandrolone in Healthy Adults: A Relative Bioavailability Study

• Status: Completed
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the pharmacokinetics and relative bioavailability of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a small cohort of healthy adults.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Treatments: Oxandrolone

Criteria

Inclusion Criteria:

1. Male

2. Age 18 to 35 years (inclusive) at the time of screening

3. Body mass index [BMI, body weight (kg)/height (m)2] below 30 kg/m2

4. Medically healthy

Exclusion Criteria:

1. Known allergy to anabolic steroids

2. Use of any prescription medication currently or within 14 days prior to dosing

3. Use of tobacco or nicotine containing products (including smoking cessation products), within 6 months prior to dosing

4. Any chronic medical condition

5. Seated blood pressure <90/40 mmHg or >140/90 mmHg at screening

6. Heart rate <40 or >99 at screening

7. Subjects who have taken any investigational drug within 30 days prior to first dose in the current study