Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903122
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

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

Condition or disease Intervention/treatment Phase
Dry Mouth Drug: Cevimeline Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Study Start Date : February 2009
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cevimeline
Single Dose 30 mg Capsule
Drug: Cevimeline
Other Name: Evoxac

Active Comparator: Evoxac
Single dose 30 mg capsule
Drug: Cevimeline
Other Name: Evoxac




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903122


Locations
Layout table for location information
United States, Nevada
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
Roxane Laboratories
Investigators
Layout table for investigator information
Principal Investigator: Darin Brimhall, DO Novum Pharmaceutical Research Services

Layout table for additonal information
Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01903122     History of Changes
Other Study ID Numbers: CEVI-C30-PVFS-1
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Cevimeline
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action