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 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Treatment B (Fimasartan/Linagliptin)
- Conditions
- Hypertension
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.
Detailed Description
This is an open-label, randomized, 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/Linagliptin and co-administration of Fimasartan and Linagliptin.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male 19-50 years of age.
- •Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
- •Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
- •Medically healthy with no clinically significant medical history.
Exclusion Criteria
- •History or presence of clinically significant medical or psychiatric condition or disease.
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- •Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
- •Plasma donation within a month prior to the first dose of study drug.
- •Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
Arms & Interventions
Sequence B
Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Intervention: Treatment B (Fimasartan/Linagliptin)
Sequence A
Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.
Intervention: Treatment A (Fimasartan, Linagliptin)
Sequence A
Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.
Intervention: Treatment B (Fimasartan/Linagliptin)
Sequence B
Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Intervention: Treatment A (Fimasartan, Linagliptin)
Sequency C
Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Intervention: Treatment A (Fimasartan, Linagliptin)
Sequency C
Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Intervention: Treatment B (Fimasartan/Linagliptin)
Outcomes
Primary Outcomes
Cmax
Time Frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Maximum concentration of drug in plasma of Fimasartan, Linagliptin
AUClast
Time Frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin