NCT05150626

A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects

An Open-label, Randomized, Three-period, Crossover, Single-dose Study to Evaluate the Effect of a Low-fat Meal and a Standard Meal on the Pharmacokinetics of DBPR108 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, three-period, crossover, single-dose study to evaluate the effects of a low-fat meal and a standard meal on the pharmacokinetics of DBPR108 and the safety and tolerability of DBPR108 under different fed states in healthy adult subjects.

Detailed description

The objective of the study is to evaluate the effect of different meal types on the pharmacokinetics of DBPR108, a potent dipeptidylpeptidase-4 inhibitor. In this open-label, randomized, three-period, crossover study, healthy subjects will receive a single dose of DBPR108 100 mg under fasted conditions and following a low-fat meal or a standard meal. Twenty-one healthy subjects will be randomized 1:1:1 to Sequence A, Sequence B, or Sequence C. This study will consist of a screening and baseline period, a treatment period, and a follow-up period. Blood samples for pharmacokinetic assessments will be taken pre-dose and up to 48 h post-dose.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	DBPR108 tablets	Drug: DBPR108, tablets, oral

Timeline

• Start date: 2022-05-29
• Primary completion: 2022-06-07
• Completion: 2022-07-14
• First posted: 2021-12-09
• Last updated: 2023-04-12

Locations

1 site across 1 country: China