Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
1 other identifier
interventional
26
1 country
1
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fasted conditions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 19, 2013
CompletedJanuary 23, 2018
January 1, 2018
Same day
July 12, 2013
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters
The comparison of the pharmacokinetic parameters of the test and reference products
33 Days
Study Arms (2)
Cevimeline
ACTIVE COMPARATORSingle Dose 30 mg Capsule
Evoxac
ACTIVE COMPARATORSingle dose 30 mg capsule
Interventions
Eligibility Criteria
You may qualify if:
- \- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novum Pharmaceutical Research Services
Las Vegas, Nevada, 89121, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darin Brimhall, DO
Novum Pharmaceutical Research Services
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 19, 2013
Study Start
February 1, 2009
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
January 23, 2018
Record last verified: 2018-01