Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

Dry Mouth Clinical Trial

Official title:

A Single Dose, Two-Treatment, Two-Period, Two Sequence Crossover Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601874
• Other study ID #: PILO-01
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 19, 2018
• Start date: September 2003
• Est. completion date: September 2003

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Mouth

Intervention

Drug:
• Pilocarpine

Locations

Country	Name	City	State
United States	CEDRA Clinical Research, LLC	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, Seven day washout