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Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects

NCT05902728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-05

No results posted yet for this study

Summary

This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.

Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.

Conditions

Interventions

DRUG

HLX208

Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fed state

DRUG

HLX208

Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fast state.

DRUG

HLX208

450 mg

DRUG

HLX208

900 mg

DRUG

Itraconazole 200 mg

200 mg

DRUG

Rifampicin

600mg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-04
Primary Completion
2023-12-19
Completion
2023-12-19

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05902728 on ClinicalTrials.gov