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Comparative Pharmacokinetic Study of Aprepitant Injection in Humans

NCT06226506 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-26

No results posted yet for this study

Summary

This is a single-center, open, randomized, single-dose, two-cycle, two-sequence, crossover pharmacokinetic study in healthy adult subjects.

The trial is planned to enroll 24 healthy subjects. Subjects will be randomized to one of two groups (Group A: T-R, Group B: R-T) according to the randomization table. The washout period (dosing interval) between doses will be at least 7 days. For example, for a washout period of 7 days, all subjects will receive the appropriate drug according to the randomized schedule on Day 1 of Cycle 1 and Day 8 of Cycle 2 of the trial.

Conditions

  • Healthy

Interventions

DRUG

Test (T) Aprepitant injection

Specification: Aprepitant injection 4.4ml∶32mg. Produced and supplied by Qilu Pharmaceutical (Hainan) Co.

DRUG

Reference (R) Aprepitant injection

Specification: Aprepitant injection 4.4ml∶32mg. Produced by Heron Therapeutics, Inc and supplied by Qilu Pharmaceutical (Hainan) Co.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2024-01-25
Completion
2025-01-25

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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 NCT06226506 on ClinicalTrials.gov