NCT06427681

An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects

An Open-label, Randomized, Single-dose, Two-period Cross-over Study to Evaluate the Relative Bioavailability Between BH006 for Injection Per the Intended Dosage Regimen and Fosaprepitant and Palonosetron in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhuhai Beihai Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	BH006 for 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.
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2024-05-24
• Last updated: 2024-05-24

Regulatory

• FDA-regulated drug study