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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Single-dose crossover
Once daily Oral administration with at least 14 days of washout period |
|
| Sequence 2 | Experimental | Single-dose crossover
Once daily Oral administration with at least 14 days of washout period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geun-Seog Song, PhD | Contact | 82-2-6740-2440 | kssong1212@cj.net | |
| Eun-ji Kim | Contact | 82-2-6740-2443 | keunji@cj.net |
| Name | Affiliation | Role |
|---|---|---|
| Jae-wook Ko, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| CJ-30059 (Test) | Drug | 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. |
|
| Upto 72 hours |
| Elimination half-lie of Candesartan | Upto 72 hours |