Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07346027
PHASE1

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

Sponsor: Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-02-01

Completion Date

2026-06-01

Last Updated

2026-01-16

Healthy Volunteers

Yes

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).

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China