To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions

Overview

To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.

Full Title of Study: “A Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2004

Interventions

  • Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)
  • Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)

Arms, Groups and Cohorts

  • Experimental: 1
    • Promethazine HCl 50 mg Tablets (Sandoz, Inc)
  • Active Comparator: 2
    • Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on AUC and Cmax
    • Time Frame: 12 days

Participating in This Clinical Trial

Inclusion Criteria

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C. – Treatment for drug or alcohol dependence.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sandoz
  • Provider of Information About this Clinical Study
    • Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
  • Overall Official(s)
    • Irwin Plisco, M.D., Principal Investigator, Cetero Research, San Antonio

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