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

NCT06306872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-10

No results posted yet for this study

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

Conditions

  • Healthy Subjects

Interventions

DRUG

Sequence A ABSK-011

Subjects in sequence A will receive 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 200 mg(100 mg capsule \*2) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1).

DRUG

Sequence B ABSK-011

Subjects in sequence A will receive 200 mg(100 mg capsule \*2) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1).

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-02-23
Primary Completion
2025-09-30
Completion
2025-09-30

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 NCT06306872 on ClinicalTrials.gov