Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

Early Phase 1

Completed

• Conditions: Dry Mouth
• Interventions: Drug: Cevimeline

• Registration Number: NCT01903122
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cevimeline	Cevimeline	Single Dose 30 mg Capsule
Evoxac	Cevimeline	Single dose 30 mg capsule

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters	33 Days	The comparison of the pharmacokinetic parameters of the test and reference products

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Las Vegas, Nevada, United States