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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BH006 for injection | Experimental | 150 mg fosaprepitant/0.25 mg palonosetron intravenously 30 minutes (±1 minute) |
|
| Fosaprepitant for injection+Palonosetron hydrochloride injection | Active Comparator | 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) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BH006 for injection | Drug | 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.](streamdown:incomplete-link) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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-∞). | 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). | Period I&Period II:pre-dose to 168.000 hours after starting the infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Analysis | For aprepitant, aprepitant and palonosetron : Apparent Terminal Elimination Half-Life (t1/2). | Period I&Period II:pre-dose to 168.000 hours after starting the infusion. |
| Pharmacokinetic Analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability] | All adverse events (AE) defined by CTCAE version 5.0. | from the time of first study drug administration till end of study( Day24 Visit or Early Termination Visit) |
Inclusion Criteria:
Willing and able to provide signed and dated informed consent prior to any study-related procedures.
Willing and able to comply with all study procedures.
Subjects and their spouses must agree to use adequate contraception 14 days prior to the first dose, for the duration of study participation, and for 6 months following completion of therapy.
Healthy subjects of either gender, ≥18 years of age, or ≤ 55 years of age.
Have a body weight (BW) of ≥ 45.0 kg(female) / ≥ 50.0 kg(male) and 18 ≤ body mass index (BMI) ≤ 28 kg/m2.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Wei, PMD | Contact | +86 13500248359 | xhwei@bayhibiotech.com | |
| Tianqi Hua, PM | Contact | +86 15928870240 | tianqihua@bayhibiotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang, PI | The First Hospital of Jilin University | Principal Investigator |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C579707 | fosaprepitant |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Fosaprepitant for injection+Palonosetron hydrochloride injection | Drug | 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.](streamdown:incomplete-link) |
|
|
For aprepitant, aprepitant and palonosetron : Time to Cmax (Tmax).
| Period I&Period II:pre-dose to 168.000 hours after starting the infusion. |