Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dry Mouth
Intervention: Cevimeline (Drug)
Phase: Phase 0
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s): Darin Brimhall, DO, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories'
Cevimeline 30 mg under fed conditions
Clinical Details
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: bioequivalence determined by statistical comparison Cmax
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 cevimeline or any comparable or similar
product.
Locations and Contacts
Novum Pharmaceutical Research Services, Las Vegas, Nevada 89121, United States
Additional Information
Starting date: February 2009
Last updated: November 26, 2013
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