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Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Under Fasting Conditions

Information source: Mutual Pharmaceutical Company, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Therapeutic Equivalency

Intervention: Zolpidem Tartrate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mutual Pharmaceutical Company, Inc.

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.

Clinical Details

Official title: A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioequivalence of a Test Tablet Formulation of Zolpidem Tartrate 10 mg, to an Equivalent Dose of Ambien in Healthy Adult Subjects.

Study design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Primary outcome: Bioequivalence

Eligibility

Minimum age: 18 Years. Maximum age: 54 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Sex: Male or Female; similar proportions

- 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) yars.

- 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.

Locations and Contacts

Additional Information

Recalls, Market Withdrawals and Safety Alerts

Daily Med - Posting of Recently Submitted Labeling to the FDA

URL Pharma Generic Division

Starting date: May 2004
Ending date: May 2004
Last updated: May 27, 2008

Page last updated: June 20, 2008

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