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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: March 27, 2017
Last verified: July 2009
July 24, 2009
March 27, 2017
November 2000
November 2000   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 20 days ]
Same as current
Complete list of historical versions of study NCT00946725 on ClinicalTrials.gov Archive Site
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To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg
A Comparative Bioavailability Study of Atenolol Tablets, 100 mg
To demonstrate the relative bioavailability of atenolol tablets, 100 mg.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
  • Angina
  • Hypertension
  • Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
  • Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
  • Experimental: 1
    Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
    Intervention: Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
  • Active Comparator: 2
    Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
    Intervention: Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2000
November 2000   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00946725
11627
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Ronald Goldwater, M.D. PharmaKinetics Laboratories Inc.
Sandoz
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP