Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

Roxane Laboratories

Status and phase: Completed; Early Phase 1

Conditions: Dry Mouth

Treatments: Drug: Cevimeline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01903109

CEVI-C30-PVFD-1

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Cevimeline first, the Evoxac

Active Comparator group

Description:

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

Treatment:

Drug: Cevimeline

First Evoxac, then cevimeline

Active Comparator group

Description:

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

Treatment:

Drug: Cevimeline