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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00947063
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Allergy
 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:

U.S. FDA Resources

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)

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947063

Sponsors and Collaborators
Sandoz Inc.
Investigators
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.
ClinicalTrials.gov 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:
Antihistamine

Additional relevant MeSH terms:
Promethazine
Diphenhydramine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
 Anti-Allergic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents

ClinicalTrials.gov processed this record on May 22, 2013