Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers

Yonsei University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Test formulation; Drug: Reference formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01823913

G-0081

Details and patient eligibility

About

This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers

Enrollment: 50 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion criteria

• History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
• Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
• Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
• Use of any substance that could induce or inhibit drug metabolism enzymes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Test and reference formulations

Experimental group

Description:

Test formulation and reference formulation given orally 14 days apart in a fasted state

Treatment:

Drug: Test formulation

Drug: Reference formulation