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To Demonstrate the Relative Bioavailability of Atenolol Tablets

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913965
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
History of Changes
  Purpose

To demonstrate the relative bioavailability of Atenolol tablets.


Condition Intervention Phase
Hypertension
 Drug: Atenolol Tablets 100 mg (Cord Laboratories)
Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)
 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: Bioavailability of Atenolol Tablets

Resource links provided by NLM:

Drug Information available for: Atenolol
U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 1989
Study Completion Date: August 1989
Primary Completion Date: August 1989 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913965

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Rudolph C. Cane, Jr., M.D. PharmaKinetics Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913965     History of Changes
Other Study ID Numbers: 9103B
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on June 17, 2013