A Phase 1 interventional study of SH-1028 Tablets in Healthy Volunteer, sponsored by Nanjing Sanhome Pharmaceutical, Co., Ltd.. Status unknown. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.
Sponsored by Nanjing Sanhome Pharmaceutical, Co., Ltd. · Phase 1, Interventional, and Treatment
To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.
By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.
Nanjing Sanhome Pharmaceutical, Co., Ltd. is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fasting at last 10h before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.
Drug: SH-1028 Tablets
Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Fasting at last 10h before taking 200mg（two pills） of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.
Drug: SH-1028 Tablets
200mg of SH-1028 Tablets, orally once every cycle.
Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration [AUC(0-t)]
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of time to Cmax (tmax)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Adverse event（AE）rate and serious adverse event（SAE）rate
Time frame: From signing of informed consent to ending of the trial, about 25 days.
Pharmacokinetic of SH-1028 Tablets by assessment of maximum plasma concentration (Cmax)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (λz) [
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of Terminal half life (t1/2）
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of apparent plasma clearance (CL/F)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of apparent volume of distribution (Vz/F)
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of Mean Residence Time（MRT）
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) to AUC
Time frame: Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Nanjing Sanhome Pharmaceutical, Co., Ltd.