An interventional study of KC1036 in Healthy Subjects, sponsored by Beijing Konruns Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Beijing Konruns Pharmaceutical Co., Ltd. · Not applicable, Interventional, and Other
The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.
This is an open-label, randomized, two cycle self crossover experimental design study to assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B.
Group A:In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat diet state, KC1036 po only once (60mg QD).
Group B:In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
Beijing Konruns Pharmaceutical Co., Ltd. is the lead sponsor of 13 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the fasting state, KC1036 po only once (60mg QD) and after 7 days,in the high fat diet state,KC1036 po only once (60mg QD).
Drug: KC1036
In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
Drug: KC1036
60mg QD
Pharmacokinetics (PK) profile: Cmax
Peak Plasma Concentration
Time frame: up to 13 Days
Pharmacokinetics (PK) profile: Tmax
Time to reach the maximum plasma concentration
Time frame: up to 13 Days
Pharmacokinetics (PK) profile: T1/2
Terminal half-life
Time frame: up to 13 Days
Pharmacokinetics (PK) profile: AUC
Area under the single-dose plasma concentration-time curve
Time frame: up to 13 Days
material balance
Drug recovery
Time frame: up to 13 Days
Adverse events (AEs)
Incidence of treatment-related AEs
Time frame: up to 43 Days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Beijing Konruns Pharmaceutical Co., Ltd.