A Phase 1 interventional study of Hemay022 and Hemay022 in Food-drug Interaction, sponsored by Tianjin Hemay Oncology Pharmaceutical Co., Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Tianjin Hemay Oncology Pharmaceutical Co., Ltd · Phase 1, Interventional, and Other
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.
Tianjin Hemay Oncology Pharmaceutical Co., Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hemay022 Period 1, Fasted control → Period 2, Fed control
Drug: Hemay022
Hemay022 Period 1, Fed control → Period 2, Fasted control
Drug: Hemay022
Participants will receive a single oral dose of Hemay022 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
Participants will receive a single oral dose of Hemay022 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
Cmax
Maximum Observed Plasma Concentration for Hemay022
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
Tmax
Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Hemay022
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
AUC0-t
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Hemay022
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
AUC0-∞
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for Hemay022
Time frame: Day 1: 0-48 hours; Day 8: 0-48 hours
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Tianjin Hemay Oncology Pharmaceutical Co., Ltd