Bioequivalence Study of CJ-30059

Healthy Volunteers Clinical Trial

— CCA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02173912
• Other study ID #: CJ_CCA_102
• Status: Recruiting
• Phase: Phase 1
• First received: June 24, 2014
• Last updated: June 24, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: June 2014
• Source: CJ HealthCare Corporation
• Contact: Geun-Seog Song, PhD
• Phone: 82-2-6740-2440
• Email: kssong1212[@]cj.net
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the plasma concentration-time Curve (AUC_last) of Amlodipine		Upto 72 hours	No
Primary	Area Under the plasma concentration-time Curve (AUC_last) of Candesartan		Upto 72 hours	No
Primary	Maximum plasma concentration (Cmax) of Amlodipine		Upto 72 hours	No
Primary	Maximum plasma concentration (Cmax) of Candesartan		Upto 72 hours	No
Secondary	Time to maximum plasma concentration of Amlodipine		Upto 72 hours	No
Secondary	Time to maximum plasma concentration of Candesartan		Upto 72 hours	No
Secondary	Elimination half-lie of Amlodipine		Upto 72 hours	No
Secondary	Elimination half-lie of Candesartan		Upto 72 hours	No