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Sponsored by: |
Repros Therapeutics Inc. |
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Information provided by: | Repros Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT00749879 |
This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.
Condition | Intervention | Phase |
---|---|---|
Pharmacokinetics |
Drug: Proellex® |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex® |
Estimated Enrollment: | 12 |
Study Start Date: | August 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
25 mg Proellex capsule formulated with coarse microcrystalline cellulose Fed State |
Drug: Proellex®
25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
|
2: Experimental
25 mg Proellex capsule formulated with coarse microcrystalline cellulose Fasting State |
Drug: Proellex®
25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
|
3: Experimental
2, 25 mg Proellex capsules formulated with coarse microcrystalline cellulose Fed State |
Drug: Proellex®
25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
|
4: Experimental
2, 25 mg Proellex capsules formulated with coarse microcrystalline cellulose Fasting State |
Drug: Proellex®
25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
|
5: Experimental
2, 25 mg Proellex capsules formulated with microcrystalline cellulose Fasting State |
Drug: Proellex®
25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
|
Ages Eligible for Study: | 18 Years to 34 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Healthcare Discoveries Inc. | |
San Antonio, Texas, United States, 78229 |
Study Director: | Andre van As, MD, PhD | Repros Therapeutics Inc. |
Responsible Party: | Repros Therapeutics, Inc. ( Andre vanAs, MD, PhD ) |
Study ID Numbers: | ZP-008 |
Study First Received: | September 5, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00749879 |
Health Authority: | United States: Food and Drug Administration |
PK Pharmacokinetics |