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

July 24, 2009
July 24, 2009
November 2000
November 2000   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 20 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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)
Not Provided

*   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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00946725
11627
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
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