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Completed

NCT Number: NCT02060019

Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook university hospital

Deagu, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male volunteers in the age between 20 and 55 years old
  • The weight range is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9
  • Subjects with no history of any significant chronic disease
  • Judged to be in good health on the basis of their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration
  • Willing to adhere to protocol requirements and sign a informed consent form

Exclusion criteria

  • History of clinically significant allergies including drug allergies
  • History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
  • History of genetic muscular disease and family history
  • hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
  • AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range
  • Creatinine clearance < 80mL/min
  • Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
  • Serious injury, surgery and acute illness within 4 weeks prior to drug administration
  • History of alcohol, smoking abuse
  • alcohol > 21 units/week, 1 unit=10g=12.5mL of pure alcohol
  • smoking > 10 cigarettes/day
  • Use of any other medication, including herbal products, within the 2 weeks before dosing
  • Participated in a previous clinical trial within 3 months prior to drug administration
  • Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration
  • Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
  • Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
  • Subjects considered as unsuitable based on medical judgement by investigators

Treatment and study plan

administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.

Drug

Primary outcomes

  1. Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)

    Time frame: 3 days

    after steady state (Administration of Investigational Product 7day or 10days)

Secondary outcomes

  1. Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2

    Time frame: 3 days

    steady state (Administration of Investigational Product)

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Dec 29, 2016

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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