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Completed

NCT Number: NCT03912285

The Pharmacokinetic Interaction Between Amlodipine and Losartan

This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Seoul, 136-705, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers aged between ≥ 20 and ≤ 45 years old
  • Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
  • Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
  • Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion criteria

  • History or presence of a clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
  • With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
  • Any medical history that may affect drug absorption, distribution, metabolism, and excretion
  • Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
  • Any clinically significant active chronic disease

Treatment and study plan

Amlodipine10mg

Drug

Amlodipine 10mg will be administered orally twice a day for 9 days

Losartan potassium 100mg

Drug

Losartan 100mg will be administered orally once a day for 9 days

Amlodipine plus Losartan

Drug

Amlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan"

Primary outcomes

  1. AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

  2. Cmax,ss(Maximum plasma concentration of the drug at steady state)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

Secondary outcomes

  1. Cmin,ss(Minimum concentration of the drug in plasma at steady state)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

  2. Tmax,ss(Time to maximum plasma concentration at steady state)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

  3. 1/2(Terminal elimination half-life)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

  4. CLss/F(Apparent total body clearance of the drug from plasma at steady state)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

  5. Vd,ss/F(Apparent volume of distribution at steady state)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

  6. PTF(Peak-to-trough fluctuation)

    Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Hanmi Pharmaceutical co., ltd.

Registry information

Official study title

Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2019
Registry last updated
Apr 12, 2019

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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