Bioequivalence Study of CJ-30059

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designed to evaluate the bioequivalence of the two treatments, the administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine besylate, in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Amlodipine; Candesartan; Candesartan cilexetil

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