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CompletedNCT00833937Updated Aug 19, 2024Results posted

Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

A Phase 1 interventional study of Zolpidem 10 mg tablets and AMBIEN® 10 mg tablets in Healthy, sponsored by Teva Pharmaceuticals USA. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Teva Pharmaceuticals USA · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle \& Co.) in healthy, adult, non-smoking subjects under non-fasting conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • Healthy Subjects
03

In context

Lead sponsor

Teva Pharmaceuticals USA is the lead sponsor of 171 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on 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 a history of allergic responses to the class of drug being tested will be excluded from the study.
  • Subjects who 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 who 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) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 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 or inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Zolpidem

    Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period

    Drug: Zolpidem 10 mg tablets

  • Active comparator
    Ambien®

    Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period

    Drug: AMBIEN® 10 mg tablets

Interventions

  • DrugZolpidem 10 mg tablets

    1 x 10 mg

  • DrugAMBIEN® 10 mg tablets

    1 x 10 mg

06

What researchers measure

Primary outcomes

  1. Cmax - Maximum Observed Concentration

    Bioequivalence based on Cmax

    Time frame: Blood samples collected over 24 hour period

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

    Bioequivalence based on AUC0-inf

    Time frame: Blood samples collected over 24 hour period

  3. 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

    Time frame: Blood samples collected over 24 hour period

07

Results

Posted Aug 18, 2009

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneZolpidem (Test) FirstAmbien® (Reference) First
Started1212
Completed1212
Not completed00
Washout
Participant flow — Washout
MilestoneZolpidem (Test) FirstAmbien® (Reference) First
Started1212
Completed1112
Not completed10
Withdrew: Withdrawal by subject10
Second Intervention
Participant flow — Second Intervention
MilestoneZolpidem (Test) FirstAmbien® (Reference) First
Started1112
Completed1112
Not completed00

Outcome measures

PrimaryCmax - Maximum Observed Concentration

Bioequivalence based on Cmax

Time frame:
Blood samples collected over 24 hour period
Reported as:
Mean · ng/mL
Cmax - Maximum Observed Concentration
ng/mLZolpidemAmbien®
Cmax - Maximum Observed Concentration117.313 ± 42.878116.452 ± 40.419
Statistical analysis
  • Zolpidem vs Ambien® · Ratio of geometric means: 99.7 · 90% CI 93.9 to 106Bioequivalence is established when 90% Confidence Interval falls within 80-125.
PrimaryAUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf

Time frame:
Blood samples collected over 24 hour period
Reported as:
Mean · ng*h/mL
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
ng*h/mLZolpidemAmbien®
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)541.580 ± 279.254543.732 ± 273.918
Statistical analysis
  • Zolpidem vs Ambien® · Ratio of geometric means: 97.8 · 90% CI 92.6 to 103Bioequivalence is established when 90% Confidence Interval falls within 80-125.
PrimaryAUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t

Time frame:
Blood samples collected over 24 hour period
Reported as:
Mean · ng*h/mL
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
ng*h/mLZolpidemAmbien®
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)530.272 ± 271.461531.866 ± 265.350
Statistical analysis
  • Zolpidem vs Ambien® · Ratio of geometric means: 97.9 · 90% CI 92.7 to 103Bioequivalence is established when 90% Confidence Interval falls within 80-125.

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Zolpidem (Test) FirstAmbien® (Reference) FirstTotal
<=18 years000
Between 18 and 65 years121224
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Zolpidem (Test) FirstAmbien® (Reference) FirstTotal
Female123
Male111021
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Zolpidem (Test) FirstAmbien® (Reference) FirstTotal
Caucasian9716
Black246
Hispanic112
Region of Enrollment
Region of Enrollment(participants)Zolpidem (Test) FirstAmbien® (Reference) FirstTotal
United States121224
08

Study locations

2 sites
  • Novum Pharmaceutical Research Services
    Pittsburgh, Pennsylvania 15206, United States
  • Bioassay Laboratory, Inc.
    Houston, Texas 77099, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00833937
Lead sponsor
Teva Pharmaceuticals USA
First posted
Feb 2, 2009
Start date
Mar 2002
Primary completion
Mar 2002
Completion
Mar 2002
Results posted
Aug 18, 2009
Last update
Aug 19, 2024

Study contacts

Shirley Ann Kennedy, M.D.
principal investigator · Novum Pharmaceuticals Research Services

Oversight

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

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