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CompletedNCT00694317Updated Jan 23, 2018

Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

An interventional study of Zaleplon in Short Term Treatment of Insomnia, sponsored by Roxane Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

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

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Conditions studied

  • Short Term Treatment of Insomnia

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

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Lead sponsor

Roxane Laboratories is the lead sponsor of 98 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Interventions

  • DrugZaleplon

    Short term treatment of insomnia

    Also known as: Sonata

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What researchers measure

Primary outcomes

  1. Bioequivalence

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Study locations

1 site
  • Novum Pharmaceutical Research Services
    Houston, Texas 77042, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00694317
Lead sponsor
Roxane Laboratories
First posted
Jun 10, 2008
Start date
Feb 2004
Primary completion
Feb 2004
Completion
Feb 2004
Last update
Jan 23, 2018

Study contacts

So Ran Hong, M.D.
principal investigator · Novum Pharmaceutical Research Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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