Bioequivalence Study of CJ-30059
- Conditions
- Healthy Volunteers
- Interventions
- Drug: CJ-30059 (Test)
- Registration Number
- NCT02173912
- Lead Sponsor
- HK inno.N Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 32
- 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
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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
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Subjects with a history of clinically significant allergies
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Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) Single-dose crossover 1. Test: CJ-30059 2. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg Once daily Oral administration with at least 14 days of washout period Sequence 1 CJ-30059 (Test) Single-dose crossover 1. Test: CJ-30059 2. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg Once daily Oral administration with at least 14 days of washout period Sequence 2 Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference) Single-dose crossover 1. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg 2. Test: CJ-30059 Once daily Oral administration with at least 14 days of washout period Sequence 2 CJ-30059 (Test) Single-dose crossover 1. Reference: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg 2. Test: CJ-30059 Once daily Oral administration with at least 14 days of washout period
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of