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

B

Boryung

Status and phase

Completed
Phase 1

Conditions

Hypertension
Diabetes

Treatments

Drug: Treatment A (Fimasartan, Linagliptin)
Drug: Treatment B (Fimasartan/Linagliptin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03609294
BR-FLC-CT-102

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

67 participants in 3 patient groups

Sequence A
Experimental group
Description:
Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.
Treatment:
Drug: Treatment A (Fimasartan, Linagliptin)
Drug: Treatment B (Fimasartan/Linagliptin)
Sequence B
Experimental group
Description:
Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Treatment:
Drug: Treatment A (Fimasartan, Linagliptin)
Drug: Treatment B (Fimasartan/Linagliptin)
Sequency C
Experimental group
Description:
Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Treatment:
Drug: Treatment A (Fimasartan, Linagliptin)
Drug: Treatment B (Fimasartan/Linagliptin)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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