NCT03662568

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

A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	GLS4	Administered GLS4 120 mg orally three times daily in fed state
DRUG	RTV	Administered RTV 100 mg orally three times daily in fed state
DRUG	ETV	Administered orally ETV 0.5 mg once daily in fasted state
DRUG	TDF	Administered TDF 300 mg orally once daily in fasted state

Timeline

• Start date: 2018-06-26
• Primary completion: 2018-07-31
• Completion: 2019-06-10
• First posted: 2018-09-07
• Last updated: 2019-10-09

Locations

1 site across 1 country: China