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

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

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

Condition Intervention Phase
Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)
Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Promethazine HCl 50 mg Tablets (Sandoz, Inc)
Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)
Active Comparator: 2
Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)
Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00947063

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: Irwin Plisco, M.D. Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00947063     History of Changes
Other Study ID Numbers: B043722
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:

Additional relevant MeSH terms:
Anesthetics, Local
Anti-Allergic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on October 06, 2015