Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

This study has been completed.

First Received on January 15, 2008. Last Updated on February 5, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602524

Purpose

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.

Condition	Intervention
Dry Mouth	Drug: Pilocarpine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose, Two-Period, Two-Treatment, 2-Sequence Crossover Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

Resource links provided by NLM:

MedlinePlus related topics: Dry Mouth

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:	August 2004
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (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: NCT00602524

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:	Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00602524 History of Changes
Other Study ID Numbers:	PILO-03
Study First Received:	January 15, 2008
Last Updated:	February 5, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012