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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ Amlodipine/Valsartan 10/160mg; Drug: Novartis Exforge 10/160mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494727

CJ_AMV_101

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

CJ Amlodipine/Valsartan 10/160mg

Experimental group

Treatment:

Drug: CJ Amlodipine/Valsartan 10/160mg

Novartis Exforge 10/160mg

Active Comparator group

Treatment:

Drug: Novartis Exforge 10/160mg