Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

NCT ID: NCT01903122

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-02-28

Brief Summary

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

Detailed Description

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Conditions

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Dry Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cevimeline

Single Dose 30 mg Capsule

Group Type ACTIVE_COMPARATOR

Cevimeline

Intervention Type DRUG

Evoxac

Single dose 30 mg capsule

Group Type ACTIVE_COMPARATOR

Cevimeline

Intervention Type DRUG

Interventions

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Cevimeline

Intervention Type DRUG

Other Intervention Names

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Evoxac

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roxane Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darin Brimhall, DO

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

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Novum Pharmaceutical Research Services

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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CEVI-C30-PVFS-1

Identifier Type: -

Identifier Source: org_study_id

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