Hypertension Clinical Trial
Official title:
A Phase I Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
Verified date | January 2018 |
Source | Boryung Pharmaceutical Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.
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). |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyungpook National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Boryung Pharmaceutical Co., Ltd |
Korea, Republic of,
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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