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An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects

NCT06427681 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhuhai Beihai Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hong Zhang, PI · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2024-09-30
Completion
2024-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06427681 on ClinicalTrials.gov