The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon
Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
- 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