Back to resultsBioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions
Primary Purpose
Dry Mouth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pilocarpine
Sponsored by
About this trial
This is an interventional treatment trial for Dry Mouth
Eligibility Criteria
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.
Sites / Locations
- CEDRA Clinical Research, LLC
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00601874
Brief Title
Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions
Official Title
A Single Dose, Two-Treatment, Two-Period, Two Sequence Crossover Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pilocarpine
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two period, Seven day washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel V Freeland, DO
Organizational Affiliation
CEDRA Clinical Research, LLC,
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEDRA Clinical Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions
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