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This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1301 and Midazolam or Atorvastatin Group | Experimental | HRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1301 Tablets | Drug | HRS-1301 tablets. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) | Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf) | Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Maximum observed plasma concentration (Cmax) | Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last) | Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf) | Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum observed concentration (Tmax) | Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Terminal elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang | Contact | +86-0518-82342973 | ying.wang.yw30@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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An open-label, single-arm, fixed-sequence, pharmacokinetics, safety and tolerability study.
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| Atorvastatin Calcium Tablets |
| Drug |
Atorvastatin Calcium tablets. |
|
| Midazolam oral solution | Drug | Midazolam oral solution. |
|
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
| Up to 15 days. |
| Apparent clearance (CL/F) | Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Apparent volume of distribution (Vz/F) | Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Maximum observed plasma concentration (Cmax) | Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) | Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) | Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets. | Up to 15 days. |
| Apparent volume of distribution (Vz/F) | Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Apparent clearance (CL/F) | Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Time to reach maximum observed concentration (Tmax) | Plasma pharmacokinetics (PK) parameters of Atorvastatin 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Terminal elimination half-life (t1/2) | Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Maximum observed plasma concentration (Cmax) | Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) | Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf) | Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets. | Up to 18 days. |
| Incidence and severity of adverse events (AEs) | Safety and Tolerability. | Up to 22 days. |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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