Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT06325761
Brief Summary:
This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.
Detailed Description:
The study consists of two parts: a pilot study and a formal study. The pilot study involves four healthy subjects who will receive a single dose of SY-5007 80 mg after a meal (high-fat meal) for Period 1 and on an empty stomach for Period 2, with observation and PK blood sample collection.
The formal study plans to enroll 24 healthy subjects, divided into Groups A and B, each with 12 subjects, receiving a dose of 160 mg. Group A will receive the drug on an empty stomach for Period 1, followed by administration after a meal (high-fat meal) for Period 2, while Group B will follow the reverse sequence. Both groups will adopt a two-period, two-treatment crossover design with a washout period of 7 days. If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007, subsequent trial protocols may be adjusted.
Study:
NCT06325761
Study Brief:
Protocol Section:
NCT06325761