NCT05828485

Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects

A Single-dose, Open-label Clinical Study to Evaluate the Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Wuhan Createrna Science and Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This was a single-center, single-dose, open-label clinical study. 12 subjects were randomly assigned in a 1:1 ratio to one of the following dosing sequences (sequence 1: AB; Sequence 2: BA). Each dosing sequence consisted of two cycles, one dose per cycle, with a 5-day washout period between doses.

Detailed description

A: A single dose of MY008211A tablets was administered in the fasting state (fasting for at least 10 h with water as needed). B: A single dose of MY008211A tablets was administered after a standard high-fat, high-calorie fed.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
DRUG	MY008211A tablets	A single dose of MY008211A tablet was administered after fasting and high-fat, high-calorie feeding

Timeline

• Start date: 2022-09-26
• Primary completion: 2022-10-23
• Completion: 2022-10-23
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: China