Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

Roxane Laboratories

Status

Completed

Conditions

Dry Mouth

Treatments

Drug: Pilocarpine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00602524

PILO-03

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.