Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

Early Phase 1CompletedNCT01903122

Roxane Laboratories26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Mouth

Interventions

CevimelineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters

The comparison of the pharmacokinetic parameters of the test and reference products

Time frame: 33 Days

Data from ClinicalTrials.gov

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