Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions
Not Applicable
Completed
- Conditions
- Dry Mouth
- Registration Number
- NCT00618059
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of pilocarpine explain its efficacy in treating xerostomia compared to SALAGEN®?
How does the bioavailability of 7.5 mg pilocarpine tablets compare to SALAGEN® under fed conditions in dry mouth patients?
Are there specific biomarkers that correlate with response to pilocarpine in Sjögren's syndrome-related xerostomia?
What adverse event profiles differentiate Roxane's 7.5 mg pilocarpine from the standard-of-care SALAGEN® in bioequivalence trials?
How do cholinergic agonists like pilocarpine compare to muscarinic receptor modulators in managing radiation-induced dry mouth?
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States
CEDRA Clinical Research, LLC🇺🇸Austin, Texas, United States