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A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021 - Trial NCT06322706

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.

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NCT06322706
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06322706
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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

Study Focus

Healthy Subjects

ABSK021

Interventional

drug

Sponsor & Location

Abbisko Therapeutics Co, Ltd

Timeline & Enrollment

Phase 1

Mar 28, 2024

Dec 31, 2025

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 examination
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Routine child health examination
Examination and observation for other reasons

Data Source

ClinicalTrials.gov

NCT06322706

Non-Device Trial