Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

Completed · Early Phase 1

Conditions studied: Dry Mouth

In brief

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

Key facts

Study ID

NCT01903122

Run by

Roxane Laboratories

People needed

26

Starts

2009-02-01

Expected to finish

2009-02-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Novum Pharmaceutical Research Services — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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