Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

• Status: Not yet recruiting
• Trial end date: 2023-01-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Midazolam

Criteria

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.