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| Name | Class |
|---|---|
| R&G Pharma Studies Co.,Ltd. | INDUSTRY |
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To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and tolerability profile in healthy Chinese volunteers to be the reference for protocol designs of subsequent clinical trials.
This is a single center, randomized, open-label, two-arm, parallel design, phase I study that using TG-2349 or DAG181 alone, or TG-2349 plus DAG181 to evaluate the drug-drug reactions, the pharmacokinetics, and tolerability profile in healthy Chinese volunteers. The results will be the reference for protocol designs of subsequent clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG-2349 (400 mg) plus DAG181 (200 mg) | Experimental | Dosing period 1 (Day 1 to 7): TG-2349 alone;Dosing period 2 (Day 8 to 14): TG-2349+DAG181 |
|
| DAG181 (200 mg) plus TG-2349 (400 mg) | Experimental | Dosing period 1 (Day 1 to 7): DAG181 alone;Dosing period 2 (Day 8 to 14): TG-2349+DAG181 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-2349 (400 mg) plus DAG181 (200 mg) | Drug | Dosing period 1 (Day 1 to 7): TG-2349 400 mg; Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax(ss) | Maximum Plasma Concentration in a stable state | 14 weeks |
| Ctrough(ss) | Trough Plasma Concentration in a stable state | 14 weeks |
| AUC(0-τ, ss) | Area Under the Plasma Concentration vs. Time Curve | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax: Maximum Plasma Concentration, | 14 weeks |
| Ctrough | Ctrough: Trough Plasma Concentration | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pingsheng Xu | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | China |
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randomized, open-label, two-arm, parallel design
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| DAG181 (200 mg) plus TG-2349 (400 mg) | Drug | Dosing period 1 (Day 1 to 7): DAG181 200 mg; Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg |
|
| Tmax | Time at Which Maximum Plasma Concentration is Observed | 14 weeks |
| AUC(0-24) | AUC(0-24): Area Under the Plasma Concentration vs. Time Curve 0-24 hours | 14 weeks |
| Tmax(ss) | Tmax(ss): Time at Which Maximum Plasma Concentration is Observed in a stable state | 14 weeks |
| λz | λz: Terminal disposition rate constant/terminal rate constant | 14 weeks |
| AUC(0-last) | AUC(0-last): Area Under the Plasma Concentration vs. Time Curve 0 - the last dose | 14 weeks |
| AUC(0-inf) | AUC(0-inf): Area Under the Plasma Concentration vs. Time Curve 0 - infinity | 14 weeks |
| MRT | MRT: mean residence time | 14 weeks |
| CL/F | CL/F: total clearance rate | 14 weeks |
| V/F | V/F: apparent volume of distribution | 14 weeks |
| DF | DF=(Cmax - Ctrough) / (AUCss /τ) | 14 weeks |
| 12-lead ECG | including heart rate, RR, PR, QRS, QT, QTc; | 19 weeks |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | CTCAE v4.0 | 19 weeks |
| blood pressure (mmHg) | Vital signs | 19 weeks |
| pulse (beats/ min) | Vital signs | 19 weeks |
| respiratory rate (breaths/ min) | Vital signs | 19 weeks |
| body temperature (oC) | Vital signs | 19 weeks |
| General Appearance Physical examination | Physical examination | 19 weeks |
| Skin Physical examination | Physical examination | 19 weeks |
| Head and Neck Physical examination | Physical examination | 19 weeks |
| Chest region Physical examination | Physical examination | 19 weeks |
| Abdominal region Physical examination | Physical examination | 19 weeks |
| Back region Physical examination | Physical examination | 19 weeks |
| Extremities Physical examination | Physical examination | 19 weeks |
| ID | Term |
|---|---|
| C000628665 | yimitasvir |
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