Bioequivalence Study of CJ-30059

Launched by HK INNO.N CORPORATION · Jun 24, 2014

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male volunteers in the age between 19 and 55 years old(inclusive)
• • Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
• • Available for the entire study period
• • Understand the requirements of the study and voluntarily consent to participate in the study
• Exclusion Criteria:
• • Subjects with a history of gastrointestinal diseases which might significantly change absorption, distribution, metabolism and excretion (ADME) of medicines
• • Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 70 to 1000 mmHg for male subjects during screening
• • Subject with symptoms of acute disease within 14days prior to study drug administration
• • Subjects with a history of clinically significant allergies
• • Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• • Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, aspartate aminotransferase (AST) or alamin aminotransferase (ALT) \>1.5 times of the Upper Normal Limit or total bilirubin \> 1.5 times of the Upper Normal Limit)
• • History of drug abuse
• • History of caffeine, alcohol, smoking abuse
• • caffeine(coffee, tea, coke) or grapefruit juice \> 4 cups/day
• • smoking \> 20 cigarettes/day
• • alcohol \> 140 g/week
• • Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
• • Participation in any clinical investigation within 30 days prior to study drug administration
• • Subjects with whole blood donation within 60 days, component blood donation within 30days and blood transfusion within 30 days prior to study drug administration
• • Subjects who are judged unsuitable by investigators