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

  1. 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2018