Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00602524
First received: January 15, 2008
Last updated: February 5, 2008
Last verified: February 2008

January 15, 2008
February 5, 2008
August 2004
August 2004   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ] [ Designated as safety issue: No ]
Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ]
Complete list of historical versions of study NCT00602524 on ClinicalTrials.gov Archive Site
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Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions
A Single Dose, Two-Period, Two-Treatment, 2-Sequence Crossover Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

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 fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

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Interventional
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Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Dry Mouth
Drug: Pilocarpine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2004
August 2004   (final data collection date for primary outcome measure)

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 Pilocarpine or any comparable or similar product.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00602524
PILO-03
No
Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Daniel V Freeland, DO CEDRA Clinical Research, LLC
Roxane Laboratories
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP