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

NCT ID: NCT01494727

Last Updated: 2012-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-04-30

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

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

Intervention Type: DRUG

single dose

Novartis Exforge 10/160mg

Group Type: ACTIVE_COMPARATOR

Novartis Exforge 10/160mg

Intervention Type: DRUG

single dose

Interventions

CJ Amlodipine/Valsartan 10/160mg

single dose

Intervention Type: DRUG

Novartis Exforge 10/160mg

single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male volunteers in the age between 20 and 45 years old
• Body Mass Index (BMI) in the range of 19 to 27 kg/m2

Exclusion Criteria

• History of allergy or sensitivity to any drug, including amlodipine or valsartan
• History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease
• History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
• Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg)
• Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
• Clinical laboratory test values are outside the accepted normal range

• Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 1.25 times to normal range
• Total bilirubin > 1.25 times to normal range
• Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)

• 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

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_AMV_101

Identifier Type: -

Identifier Source: org_study_id