Bioavailability of Prochlorperazine Suppositories, 25 mg
Sponsor
Padagis LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00992472
Collaborator
(none)
42
1
2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bioavailability of Prochlorperazine Suppositories, 25 mg
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prochlorperazine suppositories, 25mg
|
Drug: Prochlorperazine suppositories, 25mg
|
| Active Comparator: Compazine® suppositories, 25mg
|
Drug: Compazine® suppositories, 25mg
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence according to US FDA guidelines []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Male
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PharmaKinetics Laboratories, Inc | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- Padagis LLC
Investigators
- Principal Investigator: Ferguson, M.D., PharmaKinetics Laboratories Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Padagis LLC
ClinicalTrials.gov Identifier:
NCT00992472
Other Study ID Numbers:
- 1670110293
First Posted:
Oct 9, 2009
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms: