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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03250052
Other study ID # BR-FLC-CT-101
Secondary ID
Status Completed
Phase Phase 1
First received August 10, 2017
Last updated January 16, 2018
Start date August 14, 2017
Est. completion date November 21, 2017

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.


Description:

This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date November 21, 2017
Est. primary completion date October 13, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility 1. Inclusion Criteria (Total: 5):

1. 19-50 year-old healthy male.

2. 18.5kg/m2 = Body mass index(BMI) = 27kg/m2

3. Subject who has no clinically significant medical history.

4. Subject whose informed consent is obtained and who is willing to comply with protocol.

2. Exclusion Criteria (Total: 19):

1. Sitting systolic blood pressure(SiSBP) = 140mmHg or < 115mmHg / Sitting Diastolic blood pressure(SiDBP) = 90mmHg or < 70mmHg

2. Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

3. Creatinine clearance(CrCl) < 80mL/min (using Cockcroft-Gault formula)

4. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)

5. Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
(fimasartan or linagliptin) x 7days
Part A: fimasartan, Part B: linagliptin
(fimasartan and linagliptin) x 7days
Part A & Part B: Co-administration of fimasartan and linagliptin

Locations

Country Name City State
Korea, Republic of Kyungpook 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 [Part A] AUC of fimasartan [Part A] Area under the curve(AUC) of fimasartan in steady state 0~24 hour after drug administration
Primary [Part A] Cmax of fimasartan [Part A] Cmax of fimasartan in steady state 0~24 hour after drug administration
Primary [Part B] AUC of Linagliptin [Part B] Area under the curve(AUC) of Linagliptin in Steady State 0~24 hour after drug administration
Primary [Part B] Cmax of linagliptin [Part B] Cmax of linagliptin in steady state 0~24 hour after drug administration
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