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

Last updated: February 23, 2016
Sponsor: Boryung Pharmaceutical Co., Ltd
Overall Status: Completed

Phase

1

Condition

Elevated Triglycerides (Hypertriglyceridemia)

Vascular Diseases

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT02569814
BR-FARC-CT-102
  • Ages 19-50
  • Male
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • a Healthy male subject, aged 19- 50 years

Exclusion

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

Study Design

Total Participants: 100
Study Start date:
September 01, 2015
Estimated Completion Date:
December 31, 2015

Connect with a study center

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Site Not Available

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