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Completed

NCT Number: NCT02994745

A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.

The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.

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Key information

Conditions

Hypertension, Hyperlipidemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A Healthy male aged 19-50 years
  • Body weight is over 55kg and BMI 18 ~ 27(kg/m2).
  • A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
  • A subject who is eligible according to investigator's assessment

Exclusion criteria

  • History or presence of clinically significant medical or psychiatric condition or disease.
  • History of gastrointestinal disease and resection
  • Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
  • Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
  • A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
  • Positive results for serum examination(HIV, B and C viral test, Syphilis).
  • Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
  • Participation in any other study within 3months.
  • History of whole blood donation within 2months and Apheresis 2 weeks.

Treatment and study plan

Fimasartan, Atorvastatin

Drug

Primary outcomes

  1. Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin

    Time frame: 0~48 hours after medication

  2. AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin

    Time frame: 0~48 hours after medication

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2016
Registry last updated
Jan 18, 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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