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Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

Phase 1
Completed
Conditions
Pharmacokinetics
Interventions
Drug: Treatment T
Registration Number
NCT03629067
Lead Sponsor
Boryung Pharmaceutical Co., Ltd
Brief Summary

The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • A healthy adults aged 19-50 years
Exclusion Criteria
  • History or presence of clinically significant medical or psychiatric condition or disease
  • Hypersensitivity to ingredient of IP and other medication, food
  • Participation in any other study within 3months
  • History of whole blood donation within 2months and Apheresis 1month

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Sequence ATreatment TPeriod 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period.
Sequence ATreatment RPeriod 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period.
Sequence BTreatment TPeriod 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period.
Sequence CTreatment TPeriod 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period.
Sequence CTreatment RPeriod 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period.
Sequence BTreatment RPeriod 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period.
Primary Outcome Measures
NameTimeMethod
Cmax0~144hours after Medication

Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma

Secondary Outcome Measures
NameTimeMethod
AUCinf0~144hours after medication

"Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Jongno-gu, Korea, Republic of

Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of

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