Clinical trial NCT02173912: Bioequivalence Study of CJ-30059
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine
timeFrame: Upto 72 hours
measure: Area Under the plasma concentration-time Curve (AUC_last) of Candesartan
timeFrame: Upto 72 hours
measure: Maximum plasma concentration (Cmax) of Amlodipine
timeFrame: Upto 72 hours
measure: Maximum plasma concentration (Cmax) of Candesartan
timeFrame: Upto 72 hours
Secondary outcomes:
measure: Time to maximum plasma concentration of Amlodipine
timeFrame: Upto 72 hours
measure: Time to maximum plasma concentration of Candesartan
timeFrame: Upto 72 hours
measure: Elimination half-lie of Amlodipine
timeFrame: Upto 72 hours
measure: Elimination half-lie of Candesartan
timeFrame: Upto 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae-wook Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: