Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

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

Completed

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Key information

Conditions

Dry Mouth Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cevimeline

Drug

Other names: Evoxac

Primary outcomes

bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters

Time frame: 33 Days

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

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jul 19, 2013
Registry last updated: Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed