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CompletedNCT03250052Updated Jan 18, 2018

A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers

A Phase 1 interventional study of (fimasartan or linagliptin) x 7days and (fimasartan and linagliptin) x 7days in Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Hypertension

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Keywords

  • Fimasartan
03

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

  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.
  1. 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).
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Part A

    Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days

    Drug: (fimasartan or linagliptin) x 7days · Drug: (fimasartan and linagliptin) x 7days

  • Experimental
    Part B

    Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days

    Drug: (fimasartan or linagliptin) x 7days · Drug: (fimasartan and linagliptin) x 7days

Interventions

  • Drug(fimasartan or linagliptin) x 7days

    Part A: fimasartan, Part B: linagliptin

  • Drug(fimasartan and linagliptin) x 7days

    Part A \& Part B: Co-administration of fimasartan and linagliptin

05

What researchers measure

Primary outcomes

  1. [Part A] AUC of fimasartan

    \[Part A\] Area under the curve(AUC) of fimasartan in steady state

    Time frame: 0~24 hour after drug administration

  2. [Part A] Cmax of fimasartan

    \[Part A\] Cmax of fimasartan in steady state

    Time frame: 0~24 hour after drug administration

  3. [Part B] AUC of Linagliptin

    \[Part B\] Area under the curve(AUC) of Linagliptin in Steady State

    Time frame: 0~24 hour after drug administration

  4. [Part B] Cmax of linagliptin

    \[Part B\] Cmax of linagliptin in steady state

    Time frame: 0~24 hour after drug administration

06

Study locations

1 site
  • Kyungpook National University Hospital
    Seoul, Korea, Republic of
07

References and documents

Publications

  • Kang WY, Lee HW, Gwon MR, Cho S, Shim WS, Lee KT, Yang DH, Seong SJ, Yoon YR. A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers. Drug Des Devel Ther. 2020 May 26;14:2101-2111. doi: 10.2147/DDDT.S248205. eCollection 2020. PubMed 32546973 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03250052
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Aug 15, 2017
Start date
Aug 14, 2017
Primary completion
Oct 13, 2017
Completion
Nov 21, 2017
Last update
Jan 18, 2018

Study contacts

Young-Ran Yoon, PhD
principal investigator · Kyungpook National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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