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Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01903109
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

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

Condition or disease Intervention/treatment Phase
Dry Mouth Drug: Cevimeline Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Study Start Date : February 2009
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Active Comparator: Cevimeline first, the Evoxac
Single dose 30 mg cevimeline capsule, then single dose 30 mg Evoxac capsule (after washout period)
Drug: Cevimeline
Other Name: Evoxac

Active Comparator: First Evoxac, then cevimeline
Single dose 30 mg Evoxac capsule, then single dose 30 mg cevimeline capsule (after washout period)
Drug: Cevimeline
Other Name: Evoxac




Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 33 Days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903109


Locations
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United States, Nevada
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
Roxane Laboratories
Investigators
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Principal Investigator: Darin Brimhall, DO Novum Pharmaceutical Research Services

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Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01903109     History of Changes
Other Study ID Numbers: CEVI-C30-PVFD-1
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Cevimeline
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action