Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets

NCT00658541 | Completed Phase 1 Results

• 1 other identifier: 04065
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy; Therapeutic Equivalency

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate

  The maximum or peak concentration that zolpidem tartrate reaches in the plasma.

  serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration

• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.

  serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration

• Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate

  The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant

  serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration

Study Arms (2)

Zolpidem Tartrate 10 mg Tablets

EXPERIMENTAL

A single dose of zolpidem tartrate 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

Drug: Zolpidem Tartrate 10 mg tablet

Zolpidem Tartrate (Ambien®) 10 mg Tablets

ACTIVE COMPARATOR

A single dose of Ambien® 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

Drug: Zolpidem Tartrate 10 mg tablet (Ambien®)

Interventions

Zolpidem Tartrate 10 mg tablet DRUG

10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

Zolpidem Tartrate 10 mg Tablets

Zolpidem Tartrate 10 mg tablet (Ambien®) DRUG

10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.

Also known as: Ambien®

Zolpidem Tartrate (Ambien®) 10 mg Tablets

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months
• history of malignancy, stroke, diabetes, cardiac, renal or liver disease
• 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, pulmonary disease, sleep apnea
• females who are pregnant or lactating
• history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative
• conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position
• inability to read and/or sign the consent form
• treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study
• subjects who have donated blood within four (4) weeks prior to the initial dosing for this study
• subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) Three (3) months abstinence is required.

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Zolpidem; Tablets

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 15, 2008
• Study Start: May 1, 2004
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: May 3, 2011
• Results First Posted: January 20, 2010

Record last verified: 2011-04