Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

Completed · Not applicable

Conditions studied: Short Term Treatment of Insomnia

In brief

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

Key facts

Study ID

NCT00694187

Run by

Roxane Laboratories

People needed

39

Starts

2004-01-01

Expected to finish

2004-02-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if…

• 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.

Where it is running

• Novum Pharmaceutical Research Services — Houston, Texas, United States

Full record on ClinicalTrials.gov

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