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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases
Atenolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014