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

Hypertension, Hyperlipidemia Clinical Trial

Official title:

An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995720
• Other study ID #: BR-FARC-CT-103
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2016
• Last updated: August 9, 2017
• Start date: August 26, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: August 2017
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2017
• Est. primary completion date: November 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension, Hyperlipidemia

Intervention

Drug:
• Fimasartan/Amlodipine combination drug, Rosuvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin		0~72 hour after medication
Primary	AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin		0~72 hour after medication