Bioequivalence Study of CJ-30059

NCT ID: NCT02173912

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-08-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sequence 1

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

Group Type: EXPERIMENTAL

Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)

Intervention Type: 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.

CJ-30059 (Test)

Intervention Type: 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.

Sequence 2

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

Group Type: EXPERIMENTAL

Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)

Intervention Type: 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.

CJ-30059 (Test)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae-wook Ko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Geun-Seog Song, PhD

Role: CONTACT

kssong1212@cj.net

82-2-6740-2440

Eun-ji Kim

Role: CONTACT

keunji@cj.net

82-2-6740-2443

Facility Contacts

Chaeyeong Lee

Role: primary

Other Identifiers

CJ_CCA_102

Identifier Type: -

Identifier Source: org_study_id