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

• Status: Completed
• Trial end date: 2019-06-10
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Entecavir; Ritonavir; Tenofovir

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 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.