C 122 Study Design

Considering the reported pharmacokinetic data (8) of lansoprazole, considering a = 0.05, and the bioequivalence range (0.8-1.2), a total number of 26 volunteers is expected to be sufficient to obtain a statistical power greater than 80%. Based on this estimation, 26 healthy male volunteers completed this pharmacokinetic study at Flemington Pharmaceutical Corporation, New Jersey, U.S.A. Their mean age was 25.1 + 7.2 years with a range of 18 to 45 years and mean body weight was 76.7 +10.9 kg with a range of 56.6 to 97.4 kg. Every subject completed an acceptable medical history, medication history, physical examination, an electrocardiogram, screens for HIV 1 and 2 antibodies and hepatitis B surface antigen, and a urine drug screen prior to study initiation. Selected routine clinical laboratory measurements were performed during screening. Upon completion of study, the physical examination and clinical laboratory measurements were repeated. The subjects were instructed to abstain from taking any medication for one week prior to and during the study period. Informed consents were obtained from the subjects after explaining the nature and purpose of the study. The study protocols were approved by the IRB of PRACS Institute, Fargo, North Dakota, U.S.A.

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