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NCT01903122 Clinical Trial

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

Dry Mouth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01903122
Other study ID # CEVI-C30-PVFS-1
Secondary ID
Status Completed
Phase Early Phase 1
First received July 12, 2013
Last updated January 19, 2018
Start date February 2009
Est. completion date February 2009

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fasted conditions

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cevimeline

Locations
Country Name City State
United States Novum Pharmaceutical Research Services Las Vegas Nevada

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters The comparison of the pharmacokinetic parameters of the test and reference products 33 Days
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