Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Midazolam Syrup; Drug: HEC74647PA; Drug: HEC110114

Study type: Interventional

Funder types: Industry

Identifiers

NCT05504876

HEC74647/HEC110114-DDI-101

Details and patient eligibility

About

This is a single center, open-label study to investigate whether HEC74647 and HEC110114 has an effect on the pharmacokinetic (PK) profile of midazolam（a cytochrome (CYP) 3A4 substrate）in healthy subjects

Full description

This is a single center, open-label study in healthy adult subjects. Total 14 subjects will be enrolled into the study and will be receive study drug per the defined treatment.

Enrollment: 14 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
• Be able to complete the study according to the trail protocol.
• Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
• Must be male or female between 18 to 45 years of age inclusive.
• Male and female should weigh no less than 50 kg and 45 kg respectively, and body mass index (BMI) between 18 and 28 kg /m2, inclusive.
• Physical examination and vital signs without clinically significant abnormalities.

Exclusion criteria

• Use of >5 cigarettes per day during the past 3 months.
• Known history of allergy to study drugs#or allergies constitution ( multiple drug and food allergies
• History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
• Donation or loss of blood over 450 mL within 3 months prior to screening.
• 12-lead ECG with clinically significant.
• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
• Subjects deemed unsuitable by the investigator for any other reason.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Midazolam Syrup HEC74647PA HEC110114

Experimental group

Description:

Subjects will receive 5mg Midazolam Syrup on Day 1,100 mg HEC74647PA and 600 mg HEC110114 on Day3\~8, 5mg Midazolam Syrup co-administered with 100 mg HEC74647PA and 600 mg HEC110114 on Day9.

Treatment:

Drug: HEC110114

Drug: HEC74647PA

Drug: Midazolam Syrup