A Clinical Trial to Evaluate the Drug-drug Interactions of Co-administered 'HUC2-744-A' and 'HUC2-744-B' in Healthy Adult Volunteers

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorHuons Co., Ltd.

About this trial

This study aims to evaluate the pharmacokinetic interactions between HUC2-744-A and HUC2-744-B following monotherapy or co-administration under multiple-dose conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults

Subjects with a body weight of 50 kg or more and a BMI within the range of 18.0 to 29.9 kg/m²

Disqualifiers

History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease

Presence of acute disease symptoms within 28 days prior to the first dosing

History of any disease that may affect drug absorption, distribution, metabolism, or excretion

Hypersensitivity or history of clinically significant hypersensitivity to atorvastatin, telmisartan, drugs containing ingredients of the same class, or other medications (e.g., aspirin, antibiotics, dihydropyridine derivatives)

Trial design

Design model

Single group

Treatments tested in this trial

  • Atorvastatin Calcium

    Drug

    HUC2-744-A

  • Telmisartan

    Drug

    HUC2-744-B

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: single armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AUCτ

Area Under the Curve of telmisartan, atorvastatin

Time frame
Day 22
2

Cmax,ss

Maximum concentration at steady state of telmisartan, atorvastatin

Time frame
Day 22

Secondary outcomes

1

Cmax,ss

Maximum concentration at steady state of 2-hydroxy atorvastatin

Time frame
Day 22
2

AUCτ

Area Under the Curve of 2-hydroxy atorvastatin

Time frame
Day 22

Other outcomes

Sponsors and contacts

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