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

NCT ID: NCT01823913

Last Updated: 2013-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-09-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test and reference formulations

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

Group Type: EXPERIMENTAL

Test formulation

Intervention Type: DRUG

A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg

Reference formulation

Intervention Type: DRUG

A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg

Interventions

Test formulation

A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg

Intervention Type: DRUG

Reference formulation

A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyungsoo Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

Kim Y, Son M, Lee D, Roh H, Son H, Chae D, Bahng MY, Park K. Pharmacokinetic comparison of 2 fixed-dose combination tablets of amlodipine and valsartan in healthy male Korean volunteers: a randomized, open-label, 2-period, single-dose, crossover study. Clin Ther. 2013 Jul;35(7):934-40. doi: 10.1016/j.clinthera.2013.05.021.

Reference Type: DERIVED

PMID: 23870605 (View on PubMed)

Other Identifiers

G-0081

Identifier Type: -

Identifier Source: org_study_id