A Phase 1 interventional study of Jaktinib Hydrochloride Tablets and Itraconazole capsule in Healthy Volunteers, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 1, Interventional, and Treatment
The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.
Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day.
Drug: Jaktinib Hydrochloride Tablets · Drug: Itraconazole capsule
1. Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day. 2. Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal.
Drug: Jaktinib Hydrochloride Tablets · Drug: Rifampicin Capsules
Oral Jaktinib 100 mg for 1 day
Also known as: Jaktinib
Oral Itraconazole 200 mg for 9 day
Also known as: Itraconazole
Oral Rifampicin 600 mg for 11 day
Also known as: Rifampicin
Cmax
Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration
Time frame: Up to 32 Days
AUC
Area under the plasma concentration versus time curve (AUC) of Jaktinib
Time frame: Up to 32 Days
Adverse Events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Time frame: Up to 32 Days
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd