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.

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference); Drug: CJ-30059 (Test)

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Geun-Seog Song, PhD; Phone Number: 82-2-6740-2440; Email: kssong1212@cj.net
• Study Contact Backup: Name: Eun-ji Kim; Phone Number: 82-2-6740-2443; Email: keunji@cj.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Chaeyeong Lee
    • Principal Investigator: Jae-Wook Ko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; 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); 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.; Drug: CJ-30059 (Test); 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.
Experimental: Sequence 2; 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); 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.; Drug: CJ-30059 (Test); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Jae-wook Ko, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: CJ_CCA_102