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Completed

NCT Number: NCT05504876

Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Midazolam Syrup

Drug

Administered Midazolam Syrup 5 mg orally once daily in fed state;

HEC74647PA

Drug

Administered HEC74647PA 100 mg orally once daily in fed state;

HEC110114

Drug

Administered HEC110114 600 mg orally once daily in fed state;

Primary outcomes

  1. Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)

    Time frame: Day 1, Day9

  2. Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-t)

    Time frame: Day 1, Day9

  3. Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0- 0-∞)

    Time frame: Day 1, Day9

  4. Incidence of adverse eventsECG, or Physical Examination.

    Time frame: Day 1 to Day16

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose of HEC74647 and HEC110114 on the Pharmacokinetics of Midazolam, and Their Metabolites in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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