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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CJ Amlodipine/Valsartan 10/160mg; Drug: Novartis Exforge 10/160mg

• Registration Number: NCT01494727
• Lead Sponsor: HK inno.N Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-19
• Study Start: 2012-02
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-29
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CJ Amlodipine/Valsartan 10/160mg	CJ Amlodipine/Valsartan 10/160mg	-
Novartis Exforge 10/160mg	Novartis Exforge 10/160mg	-

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of