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Completed

NCT Number: NCT01823913

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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test formulation

Drug

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

Reference formulation

Drug

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

Primary outcomes

  1. Profile of Pharmacokinetics

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

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

Secondary outcomes

  1. Profile of Pharmacokinetics

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

    Tmax, Area Under Curve(0 to infinity), T_1/2

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2013
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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