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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03609294
Recruitment Status : Active, not recruiting
First Posted : August 1, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Drug: Treatment A (Fimasartan, Linagliptin) Drug: Treatment B (Fimasartan/Linagliptin) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : March 4, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: 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.

Drug: Treatment A (Fimasartan, Linagliptin)
Co-administration of Fimasartan and Linagliptin

Drug: Treatment B (Fimasartan/Linagliptin)
Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Experimental: 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.

Drug: Treatment A (Fimasartan, Linagliptin)
Co-administration of Fimasartan and Linagliptin

Drug: Treatment B (Fimasartan/Linagliptin)
Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Experimental: 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.

Drug: Treatment A (Fimasartan, Linagliptin)
Co-administration of Fimasartan and Linagliptin

Drug: Treatment B (Fimasartan/Linagliptin)
Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg




Primary Outcome Measures :
  1. Cmax [ Time Frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration ]
    Maximum concentration of drug in plasma of Fimasartan, Linagliptin

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male 19-50 years of age.
  2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
  3. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
  4. Medically healthy with no clinically significant medical history.

Exclusion Criteria:

  1. History or presence of clinically significant medical or psychiatric condition or disease.
  2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
  3. Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
  4. Plasma donation within a month prior to the first dose of study drug.
  5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609294


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Dahak-ro, Korea, Republic of, 03080
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University Hospital

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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03609294     History of Changes
Other Study ID Numbers: BR-FLC-CT-102
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Linagliptin

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action