Trials / Completed
CompletedNCT03638076
The Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules
Un-randomized, Open, Multiple-Dose Study to Evaluate the Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules (GLS4) /Ritonavir Tablets(RTV) in Patients With Chronic Hepatitis B
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Sunshine Lake Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B
Detailed description
Un-randomized, open Multiple-Dose Study to Evaluate the Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B 20 subjects with Chronic Hepatitis B will be enrolled. 10 subjects will be assigned to group A and receive Morphothiadine Mesilate Capsule 120mg and Ritonavir Tablet 100mg twice daily for 48 weeks. 10 subjects will be assigned to group B and receive Morphothiadine Mesilate Capsule 120mg and Ritonavir Tablet 100mg three times daily for 48 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GLS4 | Subject in group A will receive Mesilate Capsule 120mg twice daily. Subject in group B will receive Mesilate Capsule 120mg three times daily. |
| DRUG | RTV | Subject in group A will receive Ritonavir tablet 100mg twice daily.Subject in group B will receive Ritonavir tablet 100mg three times daily. |
Timeline
- Start date
- 2017-07-26
- Primary completion
- 2018-11-22
- Completion
- 2018-11-29
- First posted
- 2018-08-20
- Last updated
- 2020-07-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03638076. Inclusion in this directory is not an endorsement.