Bioavailability of Prochlorperazine Suppositories, 25 mg
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00992472
- Lead Sponsor
- Padagis LLC
- Brief Summary
The purpose of this study is to compare prochlorperazine plasma concentrations produced after administration of the test formulation with those produced after administration of a marketed reference product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
Inclusion Criteria
- Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
Exclusion Criteria
- Positive test results for HIV or Hepatitis B or C
- History of allergy or sensitivity to Prochlorperazine or related drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Compazine® suppositories, 25mg Compazine® suppositories, 25mg - Prochlorperazine suppositories, 25mg Prochlorperazine suppositories, 25mg -
- Primary Outcome Measures
Name Time Method Bioequivalence according to US FDA guidelines
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PharmaKinetics Laboratories, Inc
🇺🇸Baltimore, Maryland, United States