Bioequivalence Study of CJ-30059 (CCA)

HK inno.N

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference); Drug: CJ-30059 (Test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02173912

CJ_CCA_102

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: CJ-30059 (Test)

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

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: CJ-30059 (Test)

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