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CompletedNCT00618059Updated Jan 23, 2018

Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions

An interventional study of Pilocarpine 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 · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

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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 28 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 Pilocarpine or any comparable or similar product.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Interventions

  • DrugPilocarpine
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What researchers measure

Primary outcomes

  1. Bioequivalence

    Time frame: Baseline, Two period, Seven day washout

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Study locations

1 site
  • CEDRA Clinical Research, LLC
    Austin, Texas 78759, United States
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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
NCT00618059
Lead sponsor
Roxane Laboratories
First posted
Feb 18, 2008
Start date
Aug 2004
Primary completion
Aug 2004
Completion
Aug 2004
Last update
Jan 23, 2018

Study contacts

Daniel V Freeland, DO
principal investigator · CEDRA Clinical Research, LLC

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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