NCT06226506

Comparative Pharmacokinetic Study of Aprepitant Injection in Humans

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-01-23
• Primary completion: 2024-01-25
• Completion: 2025-01-25
• First posted: 2024-01-26
• Last updated: 2024-01-26