Healthy
Conditions
Brief summary
This study will compare the pharmacokinetics (PK) effect of two different formulations of Gecacitinib Hydrochloride Tablets in healthy Adult participants
Interventions
Administered orally
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 18≤ age ≤ 45, male or female; * Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m\^2 (inclusive); * Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the study will be fully understood; * The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
Exclusion criteria
* Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug. * Participants may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) Of Gecacitinib and its main metabolite ZG0244 | up to 48 hours |
| Gecacitinib and its main metabolite ZG0244 AUC(0-t) | up to 48 hours |
| Gecacitinib and its main metabolite ZG0244 AUC(0-inf) | up to 48 hours |
Countries
China
Contacts
STUDY_CHAIRJason Wu
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Outcome results
None listed