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Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose

NCT06428903 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-01-20

No results posted yet for this study

Summary

Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.

The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.

Conditions

  • Healthy Volunteer

Interventions

DRUG

ADC189 tablet

ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)

DRUG

ADC189 granules

ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)

DRUG

ADC189 180mg

ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

Sponsors & Collaborators

  • Jiaxing AnDiCon Biotech 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
2024-03-12
Primary Completion
2024-09-22
Completion
2024-09-22

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 NCT06428903 on ClinicalTrials.gov