A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B in Healthy Adults

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorHuons Co., Ltd.

About this trial

This study evaluates the pharmacokinetic drug-drug interactions of repeated co-administration of HUC2A-752-A and HUC2A-752-B compared to monotherapy of each agent in healthy adults

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult volunteers

Individuals with a body weight between 50.0 kg and 90.0 kg and a BMI between 18.5 kg/m² and 29.9 kg/m²

Disqualifiers

Individuals with a history or presence of clinically significant diseases of the following systems: hepatobiliary, renal, neurological, immunological, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular , musculoskeletal, urological, psychiatric, or sexual dysfunction.

Individuals with a history of gastrointestinal diseases or gastrointestinal surgeries that could affect the safety or pharmacokinetic evaluation of the investigational product.

Individuals with a history of hypersensitivity or clinically significant hypersensitivity reactions to losartan, pitavastatin, ezetimibe, angiotensin receptor blockers, statins, or any other medications.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Losartan (COZZAR®)

    Drug

    HUC2A-752-A

  • Pitavastatin plus Ezetemibe

    Drug

    HUC2A-752-B

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUCtau,ss

Area Under the Curve

Time frame
Day 22
2

Cmax,ss

Maximum concentration at steady state

Time frame
Day 22

Secondary outcomes

1

Tmax,ss

Time to maximum concentration at steady state

Time frame
Day 22
2

t1/2

Half-life

Time frame
Day 22
3

CLss/F

Apparent Clearance

Time frame
Day 22
4

Vdss/F

Apparent Volume of Distribution at Steady State

Time frame
Day 22

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: