NCT06724549

The Effect of Food on the Pharmacokinetics of BN104 Tablets

A Study to Evaluate the Effect of Food on the Pharmacokinetics of BN104 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: BioNova Pharmaceuticals (Shanghai) LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of the clinical trial is to evaluate the effect of food on the Pharmacokinetics of BN104 tablets in healthy subjects. The main questions it aims to answer are: Whether the pharmacokinetic characteristics of BN104 tablets will be affected by food? How well is the safety and tolerability of BN104 tablets in healthy subjects? To preliminarily evaluate the effect of BN104 on the QTc interval.

Detailed description

This study adopted a single-center, randomized, open-label, single-dose, two-treatment (fasting or following a high-fat meal), two-period, and two-sequence crossover design. A total of 16 healthy subjects were enrolled in this trial. The subjects were randomized two days before dosing, and the subjects were randomly assigned to the fasting to high-fat meal group or the high-fat meal to fasting group with 8 subjects in each group. The single-dose regimen was adopted in this study, and the washout period between the periods was 7 days.

Conditions

• Health Subjects

Interventions

Type	Name	Description
DRUG	BN104	This study adopts two-treatment (fasting or following a high-fat meal), two-period, two-sequence crossover design. The subjects will be randomly assigned into one of two treatment sequences in a 1:1 ratio. A single 600 mg dose of BN104 tablets administered under fasting conditions or after a standard high-fat breakfast in period 1 and 2.

Timeline

• Start date: 2025-01-12
• Primary completion: 2025-02-13
• Completion: 2025-02-13
• First posted: 2024-12-09
• Last updated: 2025-08-08

Locations

1 site across 1 country: China