Zaleplon 10 mg Capsules Under Non-Fasting Conditions

NCT00829868 | Completed Phase 1 Results

• 1 other identifier: B046502
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 12 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 12 hour period

• AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

  Bioequivalence based on AUC0-t

  Blood samples collected over 12 hour period

Study Arms (2)

Zaleplon

EXPERIMENTAL

Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period

Drug: Zaleplon 10 mg Capsules

Sonata®

ACTIVE COMPARATOR

Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period

Drug: SONATA® 10 mg capsules

Interventions

Zaleplon 10 mg Capsules DRUG

1 x 10 mg

Zaleplon

SONATA® 10 mg capsules DRUG

1 x 10 mg

Sonata®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-smokers
• at least 18 years of age
• subjects will have a BMI (body mass index) of 30 or less

You may not qualify if:

• Subjects with a significant recent history of chronic alcohol consumption(past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma(past 5 years), diabetes,psychosis or glaucoma will not be eligible for this study.
• Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range of retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
• Subjects who have history of allergic responses to the class of drug being tested will be excluded from the study. Subjects with intolerance to alcohol or or other CNS depressants should not participate in this study.
• Subjects whou use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
• All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
• Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
• Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
• Female subjects who are pregnant , breast feeding, or whi are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) of they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.
• All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive of inconclusive results will be withdrawn from the study.
• Subjects who do not tolerate venipuncture will not be allowed to participate.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042-4712, United States

Location

MeSH Terms

Interventions

zaleplon

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• So Ran Hong, M.D.

  Novum Pharmaceuticals Research Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: February 1, 2004
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: August 21, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

US (1)