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Proellex Pharmacokinetics Bridging Study

NCT01067807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-07-08

No results posted yet for this study

Summary

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations

Conditions

  • Healthy

Interventions

DRUG

25 mg Proellex

25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) \[Original\], single dose

DRUG

25 mg Proellex

25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose

DRUG

25 mg Proellex

25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose

DRUG

50 mg Proellex

50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Andre van As, PhD, MD · Repros Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01067807 on ClinicalTrials.gov