Phase 1
Completed N=38
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions
Healthy
Source: ClinicalTrials.gov NCT00684814 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate — 191.94; 193.43 ng/mL
Summary
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate |
191.94; 193.43 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate |
682.17; 692.47 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate |
723.14; 739.63 | — |
Eligibility Criteria
Inclusion Criteria
- Sex: Male or Female; similar proportions of each preferred
- Age: At least 18 years
- Weight: must be 15% of ideal weight for height and frame
- Subjects must be in good health and physical condition as determined by medical history
- Subjects must read and sign the Consent Form
Exclusion Criteria
- History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- History of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
- History of treatment for asthma within the past five (5) years.
- History of mental depression.
- History of pulmonary disease.
- History of sleep apnea.
- Females who are pregnant or lactating.
- History of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative.
- Treatment with any other investigational drug during the four weeks prior to the initial dosing of the study.
- Donation of blood within four weeks prior to the initial dosing of the study
- Smokers or subjects who use tobacco/nicotine products. Three months abstinence is required.
Data sourced from ClinicalTrials.gov (NCT00684814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.