NCT07346027

Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects

A Randomized, Open Labeled, Two-period, Two-sequence Crossover, Phase 1 Study of F-02-2-Na Tablets in Healthy Adult Subjects：Assessment of Food Effect on Single-Dose Bioavailability

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug's pharmacokinetic profile-particularly in its absorption process-before and after food intake.

Detailed description

Approximately 12 subjects will be enrolled in Food Effect clinical trial to conduct an open-label, 2-way crossover treatment study with follow-up period. Twelve subjects will be randomized just prior to dosing to one of the 2 treatment sequences according to a randomization schedule: Sequence 1 is Period 1 Fasted State-Washout -Period 2 Fed State; Sequence 2 is Period 1 Fed State-Washout-Period 2- Fasted State.

Conditions

• Hyperuricemia With or Without Gout

Interventions

Type	Name	Description
DRUG	Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg)	Firstly, subjects will receive a fasting administration of F-02-2-Na (50 mg); secondly, a washout period of at least 4 days will be implemented; thirdly, subjects will receive a fed administration of F-02-2-Na (50 mg).
DRUG	Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg)	Firstly, subjects will receive a fed administration of F-02-2-Na (50 mg); secondly, a washout period of at least 4 days will be implemented; thirdly, subjects will receive a fasting administration of F-02-2-Na (50 mg).

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study