Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions
Not Applicable
Completed
- Conditions
- Dry Mouth
- Registration Number
- NCT00601211
- Lead Sponsor
- Roxane Laboratories
- 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 fed conditions using a single-dose, 2-treatment, 2-period, crossover design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, Two period, Seven day washout
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States