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Evaluate the Effects of Food on the Pharmacokinetics of SIM0270

NCT06536036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-02

No results posted yet for this study

Summary

This is a randomized, open label, single dose, two-period, crossover trial phase I study.

The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions.

Conditions

  • Healthy Participants

Interventions

DRUG

SIM0270

Use according to the prescribed protocol

Sponsors & Collaborators

  • Nanjing Zaiming Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

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
2024-07-23
Primary Completion
2024-10-16
Completion
2024-10-16

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 NCT06536036 on ClinicalTrials.gov