Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dry Mouth
Intervention: Pilocarpine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Daniel V Freeland, DO, Principal Investigator, Affiliation: CEDRA Clinical Research, LLC,
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.
Clinical Details
Official title: A Single Dose, Two-Treatment, Two-Period, Two Sequence Crossover Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
CEDRA Clinical Research, LLC, Austin, Texas 78759, United States
Additional Information
Starting date: September 2003
Ending date: September 2003
Last updated: January 31, 2008
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