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

PHASE1CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

September 9, 2023

Primary Completion Date

March 18, 2024

Study Completion Date

March 18, 2024

Conditions
Postpartum Depression
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

Trial Locations (1)

410013

Third Xiangya Hospital, Central South University, Changsha

All Listed Sponsors
lead

Nanjing Minova Pharmaceutical Co., Ltd.

INDUSTRY

NCT06982651 - A Study on the Safety, Pharmacokinetics, and Food Effects of MI078 Capsules | Biotech Hunter | Biotech Hunter