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To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg

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: NCT00946725
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
To demonstrate the relative bioavailability of atenolol tablets, 100 mg.

Condition or disease Intervention/treatment Phase
Angina Hypertension Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical) Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Bioavailability Study of Atenolol Tablets, 100 mg
Study Start Date : November 2000
Primary Completion Date : November 2000
Study Completion Date : November 2000

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 20 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 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

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): NCT00946725


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Ronald Goldwater, M.D. PharmaKinetics Laboratories Inc.
More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946725     History of Changes
Other Study ID Numbers: 11627
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: July 2009

Keywords provided by Sandoz:
Angina (Chest Pain)
Hypertension

Additional relevant MeSH terms:
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