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A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021

NCT06322706 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-02-18

No results posted yet for this study

Summary

Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects

Conditions

  • Healthy Subjects

Interventions

DRUG

ABSK021

ABSK021 oral

DRUG

Omeprazole

Omeprazole oral

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • Kai Huang · No. 299, Qingyang Road, Wuxi City, Jiangsu Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-03-22
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • China

Study Locations

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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 NCT06322706 on ClinicalTrials.gov