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OpenTrials
Completed

NCT Number: NCT01776047

A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

Study Design : randomized, open label, single-dose, 2-way cross-over design

Phase : Phase I

Completed

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Key information

Conditions

Healthy Male Volunteer

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

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 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion criteria

  • Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
  • Smoking over 10 cigarettes per day

Treatment and study plan

Exforge®

Drug

G-0081

Drug

Primary outcomes

  1. AUClast, Cmax

    Time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h

Secondary outcomes

  1. AUCinf, Tmax, t1/2, % AUCextra

    Time frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h

    AUCinf = AUClast + Clast/λz

    %AUCextra = [ (AUCinf - AUClast) / AUCinf ] ×100

    t1/2 = 0.693/λz

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2013
Registry last updated
Jan 25, 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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