To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergy
Intervention: Promethazine HCl 50 mg Tablets (Sandoz, Inc) (Drug); Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s):
Irwin Plisco, M.D., Principal Investigator, Affiliation: Cetero Research, San Antonio
Summary
To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under
fasting conditions.
Clinical Details
Official title: A Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under 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: N/A.
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: July 2004
Last updated: July 24, 2009
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