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To Demonstrate the Relative Bioavailability of Atenolol Tablets

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.
 
ClinicalTrials.gov Identifier: NCT00913965
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Study Description
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Brief Summary:
To demonstrate the relative bioavailability of Atenolol tablets.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Atenolol Tablets 100 mg (Cord Laboratories) Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of Atenolol Tablets
Study Start Date : July 1989
Actual Primary Completion Date : August 1989
Actual Study Completion Date : August 1989

Resource links provided by the National Library of Medicine

Drug Information available for: Atenolol

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Atenolol Tablets 100 mg (Cord Laboratories)
 Drug: Atenolol Tablets 100 mg (Cord Laboratories)
Active Comparator: 2
Atenolol Tablets 100 mg (Stuart Pharmaceutical)
 Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 11 days ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
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
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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): NCT00913965


Sponsors and Collaborators
Sandoz
Investigators
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Principal Investigator: Rudolph C. Cane, Jr., M.D. PharmaKinetics Laboratories Inc.
More Information
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Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913965    
Other Study ID Numbers: 9103B
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: June 2009
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action