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Completed

NCT Number: NCT03662568

A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate 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, crossover study in healthy adult subjects.

Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the subject will be split into two groups and receive study drug per the defined treatment periods of Day 1, Day 11-20 and Day 21.

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 1 year 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

GLS4

Drug

Administered GLS4 120 mg orally three times daily in fed state

Other names: Morphothiadine Mesilate Capsules

RTV

Drug

Administered RTV 100 mg orally three times daily in fed state

Other names: Ritonavir tablet

ETV

Drug

Administered orally ETV 0.5 mg once daily in fasted state

Other names: Entecavir table

TDF

Drug

Administered TDF 300 mg orally once daily in fasted state

Other names: Tenofovir Disoproxil Fumarate table

Primary outcomes

  1. Cmax

    Time frame: Day 1-2 and Day 21-23

    Maximum plasma concentration of study drugs

  2. AUC

    Time frame: Day 1-2 and Day 21-23

    Area under the plasma concentration-time curve of study drugs

  3. Tmax

    Time frame: Day 1-2 and Day 21-23

    Time to maximum concentration of study drugs

  4. T1/2

    Time frame: Day 1-2 and Day 21-23

    Terminal half-life of study drugs

  5. Adverse events

    Time frame: Baseline to day 23

    To assess the safety and tolerability after dosing

Secondary outcomes

  1. CL/F

    Time frame: Day 1-2 and Day 21-23

    Apparent clearance of study drugs

  2. Vz/F

    Time frame: Day 1-2 and Day 21-23

    Apparent volume of distribution of study drugs

  3. Cmin

    Time frame: Day 1-2 and Day 21-23

    Minimum 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 of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Oct 9, 2019

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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