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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00946725 |
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Date of registration:
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24/07/2009 |
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Primary sponsor: |
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Public title:
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To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg
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Scientific title:
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A Comparative Bioavailability Study of Atenolol Tablets, 100 mg |
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Date of first enrolment:
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November 2000 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00946725 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Ronald Goldwater, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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PharmaKinetics Laboratories, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Angina
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Hypertension
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Intervention(s)
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Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
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Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
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Primary Outcome(s)
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Bioequivalence based on AUC and Cmax
[Time Frame: 20 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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