Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet

NCT ID: NCT01735890

Last Updated: 2013-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-11-30

Brief Summary

The objectives of this study are:

• To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
• To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Conditions

Healthy

Keywords

Safety; Pharmacokinetics

Study Design

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

Study Groups

CJ Amlodipine/Valsartan 10/160mg

Group Type: EXPERIMENTAL

CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg

Intervention Type: DRUG

single dose

Novartis Exforge 10/160mg

Group Type: ACTIVE_COMPARATOR

CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg

Intervention Type: DRUG

single dose

Interventions

CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg

single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Years 20-45
• 18 ≤ BMI < 27kg/m²
• volunteer

Exclusion Criteria

• Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
• Subject with symptoms of acute disease within 28days prior to study medication dosing
• Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines
• Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing
• Subject with known for hypersensitivity reaction to amlodipine and valsartan
• Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. eGFR< 50mL/min ⅳ. continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L)
• Positive test results for HBs Ab, HCV Ab, Syphilis regain test
• Drug abuse or continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol(alcohol>30g/day)
• Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
• Clinically significant hypotension(SBP < 100mmHg, DBP ≤65mmHg) or hypertension(SBP 100mmHg, DBP < 65mmHg) when screening period
• Participation in any clinical investigation within 60days prior to study medication dosing
• Subjects with whole blood donation within 60days, component blood donation within 20days and blood transfusion within 30days prior to study medication dosing
• Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Nam JH, Oh M, Kim HJ, Han SK, Kim EJ, Song GS, Kim EY, Shin JG, Ghim JL, Kim HS. Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Jan;53(1):66-74. doi: 10.5414/CP202045.

Reference Type: DERIVED

PMID: 25034618 (View on PubMed)

Other Identifiers

CJ_AMV_102

Identifier Type: -

Identifier Source: org_study_id