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

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01494727

Enrollment

Registered

2011-12-19

Start date

2012-02-29

Completion date

2012-04-30

Last updated

2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Pharmacokinetics

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

Interventions

DRUGCJ Amlodipine/Valsartan 10/160mg

single dose

DRUGNovartis Exforge 10/160mg

single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026