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NCT06322706

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

A Single-Center, Open-Label, Multi-Cycle Study to Evaluate the Pharmacokinetic Profile of Different Doses of ABSK021 Capsules and the Effect of a High-Fat Meal and Omeprazole Enteric-coated Tablets on the Pharmacokinetic Profile of ABSK021 Capsules in Healthy Subjects
Abbisko Therapeutics Co, Ltd·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
ABSK021
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Abbisko Therapeutics Co, Ltd
Timeline & enrollment
Phase
Phase 1
Start date
Mar 28, 2024
End date
Dec 31, 2025
Enrollment
36 participants
Primary outcome

Cmax,tmax,AUC0-∞,AUClast

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

ICD-10 classifications
Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06322706
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06322706 through Pure Global AI's free database. This Phase 1 trial is sponsored by Abbisko Therapeutics Co, Ltd and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.