NCT05151146

A Phase 1 Study of ANJ900 Chinese Healthy Subjects

A Phase 1 Study to Investigate the Pharmacokinetics of ANJ900 (Metformin Hydrochloride Delayed-release Tablets) and the Effect of Food on the Pharmacokinetics of ANJ900 in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Anji Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.

Detailed description

This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses. All subjects will receive each of the following treatments: * Treatment 1: A single dose of 1800 mg ANJ900 in the fasted state. * Treatment 2: A single dose of 1800 mg ANJ900 in the fed state. * Treatment 3: A single dose of 1000 mg metformin IR in the fasted state. Potential subjects will be screened to assess their eligibility to enter the study within 14 days prior to the first dose administration. Subjects will be admitted into the study site on Days 1, 7, and 14 and will be confined to the study site until discharge on Days 3, 10, and 17 respectively.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ANJ900	Metformin hydrochloride delayed-release tablets
DRUG	Metformin IR	metformin hydrochloride

Timeline

• Start date: 2021-10-15
• Primary completion: 2021-12-30
• Completion: 2022-02-28
• First posted: 2021-12-09
• Last updated: 2022-06-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study