Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
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 Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Description
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 Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Conditions
Healthy
Intervention
Zolpidem Tartrate 10 mg tablet, Zolpidem Tartrate 10 mg tablet (Ambien®)
Status
Completed
Source
Mutual Pharmaceutical Company, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00658541
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pyrantel Tartrate
Broad spectrum anthelmintic for livestock.
Pentolinium Tartrate
A nicotinic antagonist that has been used as a ganglionic blocking agent in hypertension.
Antimony Potassium Tartrate
A schistosomicide possibly useful against other parasites. It has irritant emetic properties and may cause lethal cardiac toxicity among other adverse effects.
Dietary Supplements
Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)
Talc
Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)
Clinical Trials
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions
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 produc...
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the effica...
Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions
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 Phar...
Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions
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 Phar...
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving...
PubMed Articles
Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations.
PURPOSE: FDA's bioequivalence recommendation for Zolpidem Tartrate Extended Release Tablets is the first to use partial AUC (pAUC) metrics for determining bioequivalence of modif...
STUDY OBJECTIVES: To evaluate efficacy and safety of 3.5-mg zolpidem tartrate sublingual tablets (ZST) on latency to sleep onset after middle-of-the-night (MOTN) awakenings in patients with insomnia c...
Hypnotic zolpidem is a positive allosteric modulator of γ-aminobutyric acid (GABA) action, with preferential although not exclusive binding for α1 subunit-containing GABA(A) receptors. The pharmacol...
Aim:Zolpidem is a non-benzodiazepine agonist at benzodiazepine binding site in GABA(A) receptors, which is increasingly prescribed. Recent studies suggest that prolonged zolpidem treatment induces tol...
STUDY OBJECTIVES: To investigate and elucidate the role of GABA(A) receptor subunits, specifically the 2 genetic markers at the GABA(A) α1 and GABA(A) α6 receptors, in zolpidem-induced complex sleep...
