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CompletedNCT01903109Updated Jan 23, 2018

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

An Early Phase 1 interventional study of Cevimeline in Dry Mouth, sponsored by Roxane Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

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

02

Conditions studied

  • Dry Mouth

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03

In context

Xerostomia

254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.

This study's enrollment of 27 is below the median of 42 across 216 interventional studies indexed under Xerostomia.

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Lead sponsor

Roxane Laboratories is the lead sponsor of 98 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion criteria

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.
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Cevimeline first, the Evoxac

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

    Drug: Cevimeline

  • Active comparator
    First Evoxac, then cevimeline

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

    Drug: Cevimeline

Interventions

  • DrugCevimeline

    Also known as: Evoxac

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What researchers measure

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: 33 Days

07

Study locations

1 site
  • Novum Pharmaceutical Research Services
    Las Vegas, Nevada 89121, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01903109
Lead sponsor
Roxane Laboratories
Responsible party
Sponsor
First posted
Jul 19, 2013
Start date
Feb 2009
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Jan 23, 2018

Study contacts

Darin Brimhall, DO
principal investigator · Novum Pharmaceutical Research Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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