Bioequivalence Study of CJ-30059
CCA
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.
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jun 2014
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJune 25, 2014
June 1, 2014
2 months
June 24, 2014
June 24, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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
Study Arms (2)
Sequence 1
EXPERIMENTALSingle-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
EXPERIMENTALSingle-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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-wook Ko, MD, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 25, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
June 25, 2014
Record last verified: 2014-06