Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05663073
- Lead Sponsor
- Handok Inc.
- Brief Summary
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- Patients who are 19 years or older on screening
- Signed informed consent
- Healthy Volunteer
- Other inclusion applies
Exclusion Criteria
- Clinically relevant/significant findings as evaluated by the investigator
- Other exclusion applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Irbesartan/Amlodipine Fixed dose combination Irbesartan/Amlodipine FDC participants will receive one tablet of Irbesartan/Amlodipine FDC in a crossover design Co-administration of Irbesartan and Amlodipine Amlodipine participants will receive one table each of Irbesartan and Amlodipine in a crossover design Co-administration of Irbesartan and Amlodipine Irbesartan participants will receive one table each of Irbesartan and Amlodipine in a crossover design
- Primary Outcome Measures
Name Time Method Cmax of Irbesartan and Amlodipne 72 hours AUCt of Irbesartan and Amlodipne 72 hours
- Secondary Outcome Measures
Name Time Method CL/F of Irbesartan and Amlodipine 72 hours tmax of Irbesartan and Amlodipine 72 hours AUCinf of Irbesartan and Amlodipine 72 hours Vz/F of Irbesartan and Amlodipine 72 hours AUCt/AUCinf of Irbesartan and Amlodipine 72 hours half-life of Irbesartan and Amlodipine 72 hours
Trial Locations
- Locations (1)
H Plus Yangji Hospital
🇰🇷Seoul, Korea, Republic of