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To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946725
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

To demonstrate the relative bioavailability of atenolol tablets, 100 mg.


Condition Intervention Phase
Angina
Hypertension
 Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
 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 Comparative Bioavailability Study of Atenolol Tablets, 100 mg

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: 20 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2000
Study Completion Date: November 2000
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
 Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
Active Comparator: 2
Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
 Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)

  Eligibility

Ages Eligible for Study:   18 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: NCT00946725

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Ronald Goldwater, 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: NCT00946725     History of Changes
Other Study ID Numbers: 11627
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Angina (Chest Pain)
Hypertension

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 May 16, 2013