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Clinical trial

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine High Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers

ID
Name
HD-AI-102
Description
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine High Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
Trial arms
Trial start
2022-09-23
Estimated PCD
2022-11-24
Trial end
2023-04-21
Status
Completed
Phase
Early phase I
Treatment
Irbesartan/Amlodipine High FDC
Irbesartan/Amlodipine High FDC
Arms:
Irbesartan/Amlodipine High Fixed dose combination
Irbesartan
Co-administration of Irbesartan and Amlodipine High
Arms:
Co-administration of Irbesartan and Amlodipine High
Amlodipine High
Co-administration of Irbesartan and Amlodipine High
Arms:
Co-administration of Irbesartan and Amlodipine High
Size
44
Primary endpoint
AUCt of Irbesartan and Amlodipne High
72 hours
Cmax Irbesartan and Amlodipne High
72 hours
Eligibility criteria
Inclusion Criteria: * Patients who are 19 years or older on screening * Signed informed consent * Healthy Volunteer * Other inclusion applied Exclusion Criteria: * Clinically relevant/significant findings as evaluated by the investigator * Other exclusion applied
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}
Updated at
2023-08-18

1 organization

3 products

1 indication

Organization
Handok
Product
Irbesartan + Amlodipine
Indication
Healthy Control Participants
Product
Amlodipine
Product
Irbesartan