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Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted 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 fasted conditions

Clinical Details

Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted 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 comparison of the pharmacokinetic parameters

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: July 16, 2013

Page last updated: August 20, 2015

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