Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

Roxane Laboratories28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Mouth

Interventions

PilocarpineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CEDRA Clinical Research, LLC

Austin, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, Seven day washout

Data from ClinicalTrials.gov

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