Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A:Group A | Experimental | Subjects will receive GLS4+RTV on Day 1,followed by ETV on Day11-21 and co-administration with GLS4+RTV on Day 21. |
|
| Part A:Group B | Experimental | Subjects will receive ETV on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with ETV on Day 21. |
|
| Part B:Group C | Experimental | Subjects will receive GLS4+RTV on Day 1,followed by TDF on Day11-21 and co-administration with GLS4+RTV on Day 21. |
|
| Part B:Group D | Experimental | Subjects will receive TDF on Day 1,followed by GLS4+RTV on Day11-21 and co-administration with TDF on Day 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS4 | Drug | Administered GLS4 120 mg orally three times daily in fed state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration of study drugs | Day 1-2 and Day 21-23 |
| AUC | Area under the plasma concentration-time curve of study drugs | Day 1-2 and Day 21-23 |
| Tmax | Time to maximum concentration of study drugs | Day 1-2 and Day 21-23 |
| T1/2 | Terminal half-life of study drugs | Day 1-2 and Day 21-23 |
| Adverse events | To assess the safety and tolerability after dosing | Baseline to day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| CL/F | Apparent clearance of study drugs | Day 1-2 and Day 21-23 |
| Vz/F | Apparent volume of distribution of study drugs | Day 1-2 and Day 21-23 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| RTV | Drug | Administered RTV 100 mg orally three times daily in fed state |
|
|
| ETV | Drug | Administered orally ETV 0.5 mg once daily in fasted state |
|
|
| TDF | Drug | Administered TDF 300 mg orally once daily in fasted state |
|
|
| Cmin | Minimum plasma concentration of study drugs | Day 1-2 and Day 21-23 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |