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

NCT07346027 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

  • Hyperuricemia With or Without Gout

Interventions

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).

Sponsors & Collaborators

  • Xiangbei Welman Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junyan Wu, MS · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Donghui Zheng, MM · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-04-01
Completion
2026-06-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346027 on ClinicalTrials.gov