An Early Phase 1 interventional study of BH006 for injection and Fosaprepitant for injection+Palonosetron hydrochloride injection in Bioavailability, sponsored by Zhuhai Beihai Biotech Co., Ltd. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Zhuhai Beihai Biotech Co., Ltd · Early Phase 1, Interventional, and Prevention
The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).
Zhuhai Beihai Biotech Co., Ltd is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects had normal vital signs (T: 35.9\~37.6℃; P: 50\~100 beats/min; BP: 90\~139mmHg/60\~89mmHg, all including critical values) and good organ function prior to enrollment:
Exclusion Criteria:
150 mg fosaprepitant/0.25 mg palonosetron intravenously 30 minutes (±1 minute)
Drug: BH006 for injection
Fosaprepitant for injection:150 mg fosaprepitant intravenously 30 minutes (±1 minute) ; Palonosetron hydrochloride injection: 0.25 mg palonosetron in 5 mL (0.05 mg/mL) infusion time is 30 seconds (﹢5seconds) .
Drug: Fosaprepitant for injection+Palonosetron hydrochloride injection
According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study.
Also known as: EMEND®+PALONOSETRON
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration(AUC0-t).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Infinity(AUC0-∞).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
The PK endpoints will be studied and assessed by PK parameters for aprepitant :Maximum Concentration (Cmax).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
For aprepitant, aprepitant and palonosetron : Apparent Terminal Elimination Half-Life (t1/2).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Pharmacokinetic Analysis
For aprepitant, aprepitant and palonosetron : Time to Cmax (Tmax).
Time frame: Period I&Period II:pre-dose to 168.000 hours after starting the infusion.
Incidence of Adverse Events [Safety and Tolerability]
All adverse events (AE) defined by CTCAE version 5.0.
Time frame: from the time of first study drug administration till end of study( Day24 Visit or Early Termination Visit)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Zhuhai Beihai Biotech Co., Ltd