Back to resultsCrossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Primary Purpose
Dry Mouth
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cevimeline
Sponsored by
About this trial
This is an interventional treatment trial for Dry Mouth
Eligibility 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.
Sites / Locations
- Novum Pharmaceutical Research Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cevimeline
Evoxac
Arm Description
Single Dose 30 mg Capsule
Single dose 30 mg capsule
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters
The comparison of the pharmacokinetic parameters of the test and reference products
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01903122
Brief Title
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fasted conditions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cevimeline
Arm Type
Active Comparator
Arm Description
Single Dose 30 mg Capsule
Arm Title
Evoxac
Arm Type
Active Comparator
Arm Description
Single dose 30 mg capsule
Intervention Type
Drug
Intervention Name(s)
Cevimeline
Other Intervention Name(s)
Evoxac
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters
Description
The comparison of the pharmacokinetic parameters of the test and reference products
Time Frame
33 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darin Brimhall, DO
Organizational Affiliation
Novum Pharmaceutical Research Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novum Pharmaceutical Research Services
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
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