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A Study on the Safety, Pharmacokinetics, and Food Effects of MI078 Capsules

NCT06982651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-05-21

No results posted yet for this study

Summary

This study was divided into three studies, namely, a single administration study, a food impact study, and a multiple administration study.

Conditions

Interventions

DRUG

MI078

Dosage Form: Capsule Specification: 25 mg Administration and Dosage: Oral. 1 capsule per dose, once daily. Duration of Treatment: 1 day Dosage Form: Capsule Specification: 50 mg Administration and Dosage: Oral. 1 capsule per dose, once daily. Duration of Treatment: 1 day Dosage Form: Capsule Specification: 200 mg Administration and Dosage: Oral. Options include: * 1 capsule per dose, once daily; * 2 capsules per dose, once daily; * 3 capsules per dose, once daily; * 4 capsules per dose, once daily; Duration of Treatment: 1 day . Dosage Form: Capsule Specification: 200 mg Administration and Dosage: Oral. Options include: * 1 capsule per dose, twice daily; * 2 capsules per dose, twice daily; Duration of Treatment: 7 days . Dosage Form: Capsule Specification: 50mg Administration and Dosage: Oral. Options include: \- 5 capsule per dose, Three times a day Duration of Treatment: 3 days .

DRUG

Placebo

Placebo of MI078 Capsule

Sponsors & Collaborators

  • Nanjing Minova Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-09
Primary Completion
2024-03-18
Completion
2024-03-18

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06982651 on ClinicalTrials.gov