Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00618059
Collaborator
(none)
28
1
Study Details
Study Description
Brief Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGENĀ® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, Two-Period, Two-Treatment, 2-Sequence Crossover Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fed Conditions
Study Start Date
:
Aug 1, 2004
Actual Primary Completion Date
:
Aug 1, 2004
Actual Study Completion Date
:
Aug 1, 2004
Outcome Measures
Primary Outcome Measures
- Bioequivalence [Baseline, Two period, Seven day washout]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion Criteria:
-
Positive test for HIV, Hepatitis B, or Hepatitis C.
-
Treatment with known enzyme altering drugs.
-
History of allergic or adverse response to Pilocarpine or any comparable or similar product.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CEDRA Clinical Research, LLC | Austin | Texas | United States | 78759 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: Daniel V Freeland, DO, CEDRA Clinical Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00618059
Other Study ID Numbers:
- PILO-04
First Posted:
Feb 18, 2008
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018