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Completed

NCT Number: NCT02704702

A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Caucasian male 19-55 years of age.
  • Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
  • Medically healthy with no clinically significant medical history.
  • Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion criteria

  • History or presence of clinically significant medical or psychiatric condition or disease.
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
  • Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
  • Plasma donation within 7 days prior to the first dose of study drug.
  • Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

Treatment and study plan

Fimasartan

Drug

Rosuvastatin

Drug

Fimasartan + Rosuvastatin

Drug

Primary outcomes

  1. Area Under the Concentration-time Curve

    Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

    This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method

  2. Maximum Observed Concentration

    Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

    This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.

  3. Time to Reach Maximum Observed Plasma Concentration

    Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

    This Outcome is the time it takes a drug to reach Cmax

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2016
Registry last updated
Nov 2, 2018

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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