Clinical Trials Logo
  1. Home
  2. Pharmacokinetics
  3. NCT03629067
  4. Details
NCT03629067 Clinical Trial

Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

Pharmacokinetics Clinical Trial

Official title:
A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03629067
Other study ID # BR1010(BR-FAHC-CT-102)
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 13, 2018
Est. completion date December 27, 2018

Study information
Verified date January 2019
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 27, 2018
Est. primary completion date November 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment T
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
• Treatment R
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma 0~144hours after Medication
Secondary AUCinf "Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide 0~144hours after medication
See also
  Status Clinical Trial Phase
Completed NCT04092725 - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects Phase 1
Completed NCT04181008 - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers Early Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT04406415 - Oral Nafamostat in Healthy Volunteers Phase 1
Not yet recruiting NCT05421312 - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip Phase 4
Completed NCT02534753 - A Pharmacokinetics Study of Intravenous Ascorbic Acid Phase 1
Completed NCT01682408 - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability Phase 1
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01976078 - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents N/A
Completed NCT01214941 - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol Phase 4
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01260025 - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT00856570 - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects Phase 1
Completed NCT01055964 - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients Phase 3
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT01276119 - The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males Phase 1
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00984009 - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice Phase 1
Completed NCT00983242 - Drug-Drug Interaction Between Colchicine and Verapamil ER Phase 1