Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

This study has been completed.

First Received: January 15, 2008 Last Updated: January 31, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601874

Purpose

The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

Condition	Intervention
Dry Mouth	Drug: Pilocarpine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, Two-Treatment, Two-Period, Two Sequence Crossover Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Pilocarpine hydrochloride Pilocarpine Pilocarpine nitrate

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	September 2003
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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 Pilocarpine or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601874

Locations

United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Daniel V Freeland, DO

CEDRA Clinical Research, LLC,

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	PILO-01
Study First Received:	January 15, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00601874 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Autonomic Agents
Miotics
Physiological Effects of Drugs

Muscarinic Agonists
Pilocarpine
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009