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A Phase 1 Study of ANJ900 Chinese Healthy Subjects

NCT05151146 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-06-08

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

ANJ900

Metformin hydrochloride delayed-release tablets

DRUG

Metformin IR

metformin hydrochloride

Sponsors & Collaborators

  • Anji Pharma

    lead INDUSTRY

Principal Investigators

  • Dongyang Liu, MD · Peking University Third Hospital

  • Haiyan Liu, MD · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2021-12-30
Completion
2022-02-28
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 NCT05151146 on ClinicalTrials.gov