Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

Roxane Laboratories

Status

Completed

Conditions

Short Term Treatment of Insomnia

Treatments

Drug: Zaleplon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00694187

ZALE-01

Details and patient eligibility

About

The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

Enrollment

39 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 Zaleplon or any comparable or similar product.