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A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules

Healthy Subjects Clinical Trial

Official title:
A Single-center, Open-label, Multi-period Study to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules and the Effects of Low-fat Diet, High-fat Diet and Omeprazole Magnesium Enteric-coated Tablets on the Pharmacokinetic Profile of New ABSK-011 Capsules in Healthy Subjects

Clinical Trial Summary

The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose

Clinical Trial Description

This study consists of three separate parts: Part A, Part B and Part C. Part A is designed as a two-period, open-label, two-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose. Part B is designed as a three-period, open-label, three-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new ABSK-011 formulation versus the old formulation at high and low doses for single oral administration. Part C was designed as a four-period, open-label, fixed-sequence study, the main objective of which was to evaluate the effects of low-fat diet, high-fat diet and omeprazole magnesium enteric-coated tablets on PK of the new ABSK-011 formulation after a single oral administration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06306872
Study type Interventional
Source Abbisko Therapeutics Co, Ltd
Contact Yuan Lu
Phone +86-21-68910052
Email clinical@abbisko.cn
Status Recruiting
Phase Phase 1
Start date February 23, 2024
Completion date December 31, 2024
View Details
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