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

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ClinicalTrials.gov Identifier: NCT00947063
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment Phase
Allergy Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc) Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Study Start Date : July 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 12 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 Posted: July 27, 2009    Key Record Dates
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