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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:
ClinicalTrials.gov Identifier:
NCT00947063
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947063


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00947063     History of Changes
Other Study ID Numbers: B043722
First Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Antihistamine

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