Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUGCandesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)
Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between. Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between.
DRUGCJ-30059 (Test)
Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between. Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between.
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) of Candesartan | Upto 72 hours |
| Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine | Upto 72 hours |
| Area Under the plasma concentration-time Curve (AUC_last) of Candesartan | Upto 72 hours |
| Maximum plasma concentration (Cmax) of Amlodipine | Upto 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum plasma concentration of Amlodipine | Upto 72 hours |
| Time to maximum plasma concentration of Candesartan | Upto 72 hours |
| Elimination half-lie of Amlodipine | Upto 72 hours |
| Elimination half-lie of Candesartan | Upto 72 hours |
Countries
South Korea
Contacts
Primary ContactGeun-Seog Song, PhD
Backup ContactEun-ji Kim
Outcome results
None listed