Bioequivalence Study of CJ-30059

Study Overview
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Brief Summary
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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.

Official Title
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Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety Following Administration of CJ-30059 and Co-administration of Candesartan Cilexetil and Amlodipine Besylate in Healthy Volunteers.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)
* Drug: CJ-30059 (Test)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Single-dose crossover Test: CJ-30059 Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg Once daily Oral administration with at least 14 days of washout period | Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)<br>* 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.<br>Drug: CJ-30059 (Test)<br>* 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.<br>|
| Experimental: Sequence 2<br>Single-dose crossover Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg Test: CJ-30059 Once daily Oral administration with at least 14 days of washout period | Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)<br>* 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.<br>Drug: CJ-30059 (Test)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maximum plasma concentration (Cmax) of Candesartan |  | Upto 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |