To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA) (Drug); Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s): So Ran Hong, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
Summary
To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting
conditions.
Clinical Details
Official title: A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on AUC and Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: 59 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: May 2002
Last updated: April 15, 2009
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