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

Hypertension, Hyperlipidemia Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994745
• Other study ID #: BR-FAVC-CT-102
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2016
• Last updated: January 16, 2018
• Start date: December 23, 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension, Hyperlipidemia

Intervention

Drug:
• Fimasartan, Atorvastatin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin		0~48 hours after medication
Primary	AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin		0~48 hours after medication