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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteer received drug combinations(10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin) on an empty stomach |
|
| Patients with mild-to-moderate renal impairment | Experimental | Patients with mild-to-moderate renal impairment received drug combinations(10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin) on an empty stomach |
|
| Patients with moderate to severe renal impairment | Experimental | Patients with moderate to severe renal impairment received drug combinations(10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin) on an empty stomach |
|
| Patients with severe renal impairment | Experimental | Patients with severe renal impairment received drug combinations(10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin) on an empty stomach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin | Drug | Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin were provided by the Department of Pharmacy, Peking University Third Hospital, and were dissolved and mixed with normal saline respectively, and the mixing process needed to be fully stirred. Then, according to the concentration of the drug mixed solution, the corresponding volume of mixed solution was given to achieve the dosage of 10 μg midazolam, 375 μg dabigatran etexilate, 10 μg pitavastatin, 50 μg rosuvastatin and 100 μg atorvastatin. In order to avoid the food effect, the test drugs were administered on an empty stomach on the administration day in this experiment. |
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentration | Baseline and within 24 hours after administration | |
| dialysate concentration | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| biomarker concentration | Baseline and within 24 hours after administration | |
| urine concentration | Baseline |
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Inclusion Criteria:
All participants:
Participants with mild to moderate , moderate to severe , severe renal impairment or end stage renal disease:
Healthy participants ,besides:
Exclusion Criteria:
Participants with mild to moderate, moderate to severe, severe renal impairment or end stage renal disease,exclusion criteria are appended below:
Healthy participants ,exclusion criteria are appended below:
1.presence of hypoglycemia, glucose intolerance,uncontrolled type 2 diabetes mellitus (T2DM) or ketoacidosis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongyang Liu | Contact | (86)010-82266658 | liudongyang@vip.sina.com | |
| Hao Liang | Contact | 13426217031 | lianghao86@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | China |
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| Patients with end-stage renal disease | Experimental | Patients with end-stage renal disease received drug combinations(10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin) on an empty stomach |
|
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D000069604 | Dabigatran |
| C108475 | pitavastatin |
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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