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

• Sponsor: Handok Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05663073
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.6
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 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/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers
• Actual Study Start Date: Sep 13, 2022
• Actual Primary Completion Date: Dec 15, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUCt of Irbesartan and Amlodipne [72 hours]

2. Cmax of Irbesartan and Amlodipne [72 hours]

Secondary Outcome Measures

1. AUCinf of Irbesartan and Amlodipine [72 hours]

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

3. tmax of Irbesartan and Amlodipine [72 hours]

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

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

6. Vz/F of Irbesartan 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 applies

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: NCT05663073
• Other Study ID Numbers: HD-AI-101
• First Posted: Dec 23, 2022
• Last Update Posted: Jan 10, 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 10, 2023