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

NCT01823913 | Completed Phase 1

• 1 other identifier: G-0081
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Profile of Pharmacokinetics

  Cmax, Area Under Curve(0 to the last sampling time)

  0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose

Secondary Outcomes (1)

• Profile of Pharmacokinetics

  0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose

Study Arms (1)

Test and reference formulations

EXPERIMENTAL

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

Drug: Test formulation; Drug: Reference formulation

Interventions

Test formulation DRUG

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

Test and reference formulations

Reference formulation DRUG

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

Test and reference formulations

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 23870605 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2013
• First Posted: April 4, 2013
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

KR (1)