Clinical Trials Logo
  1. Home
  2. Healthy Volunteers
  3. NCT06428903

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

Healthy Volunteer Clinical Trial

Official title:
A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189

Clinical Trial 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.

Clinical Trial Description

In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed. In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06428903
Study type Interventional
Source Jiaxing AnDiCon Biotech Co.,Ltd
Contact Zhao Wei
Phone 0531-89268212
Email zhao4wei2@hotmail.com
Status Recruiting
Phase Phase 1
Start date March 12, 2024
Completion date July 31, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT06326723 - Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects Phase 1
Recruiting NCT00001367 - Diagnosis and History Study of Patients With Different Neurological Conditions
Completed NCT02699710 - Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects Phase 1
Completed NCT02231892 - Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study N/A
Not yet recruiting NCT06441916 - Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions Phase 1
Completed NCT03771586 - A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects Phase 1
Not yet recruiting NCT06337422 - Bioequivalence Study of Generic Celecoxib 200 mg Capsules Phase 1
Completed NCT03302182 - Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects Phase 1
Completed NCT05049343 - Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants Phase 1
Recruiting NCT01629108 - Normal Values in Hearing and Balance Testing
Completed NCT02947854 - Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant Phase 1
Completed NCT02534870 - Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects Phase 1
Completed NCT02224053 - Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers Phase 1
Completed NCT01697436 - A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets Phase 1
Completed NCT01711762 - A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers Phase 1
Completed NCT01676584 - A Study of Single Dose RO6811135 in Healthy Volunteers Phase 1
Completed NCT01684891 - A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers Phase 1
Completed NCT01414881 - Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects Phase 1
Completed NCT02547259 - Influence of Emotion in a Test Run Forgetfulness N/A
Completed NCT01591850 - A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers Phase 1