Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions

NCT00601211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-01-23

No results posted yet for this study

Summary

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

Conditions

Dry Mouth

Interventions

DRUG: Pilocarpine

Sponsors & Collaborators

Roxane Laboratories
lead INDUSTRY

Principal Investigators

Daniel V Freeland, DO · CEDRA Clinical Research, LLC

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: NONE
Model: CROSSOVER

Eligibility

Min Age: 18 Years
Max Age: 45 Years
Sex: ALL
Healthy Volunteers: Yes

Timeline & Regulatory

Start: 2003-09-30
Primary Completion: 2003-09-30
Completion: 2003-09-30

Countries

United States

Study Locations

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Entities

Diseases

Dry Mouth

Summary

Conditions

Interventions

Sponsors & Collaborators

Principal Investigators

Study Design

Eligibility

Timeline & Regulatory

Countries

Study Locations

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