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OpenTrials
Completed

NCT Number: NCT04232514

Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects

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Key information

About this study

This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1~7 and Day 13~19.

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.
  • Male subjects and must be 18 to 45 years of age inclusive.
  • Body weight ≥ 50 kg 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

HEC74647

Drug

Administered HEC74647 200 mg orally once daily in fed state

HEC110114

Drug

Administered HEC110114 800 mg orally once daily in fed state

Primary outcomes

  1. Adverse Events

    Time frame: From Days 1-26

    Incidence of adverse events

  2. Cmax

    Time frame: Day 7-12 and Day 19-26

    Maximum plasma concentration of study drugs

  3. AUC

    Time frame: Day 7-12 and Day 19-26

    Maximum plasma concentration of study drugs

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

A Open-label, Single Center Drug Interaction Study Between HEC74647PA Capsule and HEC110114 in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Nov 5, 2020

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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