Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers

• Sponsor: Handok Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05688085
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.4
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare pharmacokinetics and safety of Irbesartan High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Irbesartan High/Amlodipine FDC; Drug: Irbesartan High; Drug: Amlodipine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan High/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers
• Actual Study Start Date: Oct 18, 2022
• Actual Primary Completion Date: Dec 29, 2022
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irbesartan High/Amlodipine Fixed dose combination participants will receive one tablet of Irbesartan High/Amlodipine FDC in a crossover design	Drug: Irbesartan High/Amlodipine FDC; Irbesartan High/Amlodipine FDC
Experimental: Co-administration of Irbesartan High and Amlodipine participants will receive one table each of Irbesartan High and Amlodipine in a crossover design	Drug: Irbesartan High; Co-administration of Irbesartan High and Amlodipine; Drug: Amlodipine; Co-administration of Irbesartan High and Amlodipine

Outcome Measures

Primary Outcome Measures

1. AUCt of Irbesartan High and Amlodipine [72 hours]

2. Cmax of Irbesartan High and Amlodipine [72 hours]

Secondary Outcome Measures

1. AUCinf of Irbesartan High and Amlodipine [72 hours]

2. AUCt/AUCinf of Irbesartan High and Amlodipine [72 hours]

3. tmax of Irbesartan High and Amlodipine [72 hours]

4. half-life of Irbesartan High and Amlodipine [72 hours]

5. CL/F of Irbesartan High and Amlodipine [72 hours]

6. Vz/F of Irbesartan High and Amlodipine [72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus Yangji Hospital	Seoul		Korea, Republic of	08779

Sponsors and Collaborators

• Handok Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Handok Inc.
• ClinicalTrials.gov Identifier: NCT05688085
• Other Study ID Numbers: HD-AI-103
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Amlodipine; Irbesartan

Study Results

No Results Posted as of Jan 30, 2023