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Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01903109
Collaborator
(none)
27
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
27 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 Fed Conditions
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cevimeline first, the Evoxac

Single dose 30 mg cevimeline capsule, then single dose 30 mg Evoxac capsule (after washout period)

Drug: Cevimeline
Other Names:
  • Evoxac

    		•
    Active Comparator: First Evoxac, then cevimeline

    Single dose 30 mg Evoxac capsule, then single dose 30 mg cevimeline capsule (after washout period)

    Drug: Cevimeline
    Other Names:
  • Evoxac

    		•

    Outcome Measures

    Primary Outcome Measures

    1. bioequivalence determined by statistical comparison Cmax [33 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novum Pharmaceutical Research Services Las Vegas Nevada United States 89121

    Sponsors and Collaborators

    • Roxane Laboratories

    Investigators

    • Principal Investigator: Darin Brimhall, DO, Novum Pharmaceutical Research Services

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roxane Laboratories
    ClinicalTrials.gov Identifier:
    NCT01903109
    Other Study ID Numbers:
    • CEVI-C30-PVFD-1
    First Posted:
    Jul 19, 2013
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Xerostomia
    Cevimeline

    Study Results

    No Results Posted as of Jan 23, 2018