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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: March 27, 2017
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
Intervention Model: Crossover Assignment
Masking: No masking
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 ]

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   (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
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
Investigators
Principal Investigator: Rudolph C. Cane, Jr., M.D. PharmaKinetics Laboratories Inc.
  More Information

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: March 27, 2017

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on June 23, 2017