Status:
COMPLETED
Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Dry Mouth
Eligibility:
All Genders
18-45 years
Phase:
NA
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-trea...
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00618059
Start Date
August 1 2004
End Date
August 1 2004
Last Update
January 23 2018
Active Locations (1)
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1
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759