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OpenTrials
Completed

NCT Number: NCT02569814

A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias 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

Inje University Busan Paik Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • a Healthy male subject, aged 19- 50 years

Exclusion criteria

  • History of clinically significant hypersensitivity to study drug, any other drug
  • Hypotension or hypertension
  • Active liver disease
  • History of gastrointestinal disease
  • History of excessive alcohol abuse
  • Participation in any other study within 3 months

Treatment and study plan

Fimasartan/Amlodipine/Rosuvastatin

Drug

Fimasartan/Amlodipine

Drug

Rosuvastatin

Drug

Primary outcomes

  1. Cmax of Fimasartan, Amlodipine and Rosuvastatin

    Time frame: 0~144 hour after medication

  2. AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin

    Time frame: 0~144 hour after medication

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2015
Registry last updated
Feb 24, 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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