Status:
COMPLETED
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Dry Mouth
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fed conditions
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 cevimeline or any comparable or similar product.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01903109
Start Date
February 1 2009
End Date
February 1 2009
Last Update
January 23 2018
Active Locations (1)
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1
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121