Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

Dry Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903109
• Other study ID #: CEVI-C30-PVFD-1
• Status: Completed
• Phase: Early Phase 1
• First received: July 12, 2013
• Last updated: January 19, 2018
• Start date: February 2009
• Est. completion date: February 2009

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Mouth

Intervention

Drug:
• Cevimeline

Locations

Country	Name	City	State
United States	Novum Pharmaceutical Research Services	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence determined by statistical comparison Cmax		33 Days