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Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions

Roxane Laboratories logo

Roxane Laboratories

Status

Completed

Conditions

Insomnia

Treatments

Drug: Zolpidem

Study type

Interventional

Funder types

Industry

Identifiers

NCT00602719
ZOLP-02

Details and patient eligibility

About

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Enrollment

30 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 Zolpidem or any comparable or similar product.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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