Healthy
Conditions
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.
Interventions
DRUGProchlorperazine suppositories, 25mg
DRUGCompazine® suppositories, 25mg
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence according to US FDA guidelines | — |
Countries
United States
Outcome results
None listed