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This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam and Ginkgolides Meglumine Injection | Experimental | Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Ginkgolides Meglumine Injection: 25mg, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally. |
|
| Midazolam and placebo | Placebo Comparator | Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Placebo: Sodium Chloride Injection, 250 ml, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug |
| ||
| Ginkgolides Meglumine Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters:Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam. | Day 1 and Day 22 | |
| Pharmacokinetics parameters:AUC0-24h(Day 22/ Day 1)、Cmax(Day 22/ Day 1)for Midazolam. | Day 1 and Day 22 | |
| Pharmacokinetics parameters:Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection. | Day 8 | |
| Pharmacokinetics parameters:T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection. | Day 19 and Day22 | |
| Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection. | Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests. | Adverse event reports will be assessed at Day1, Day 8-22, Day 23. Vital sign measurements will be assessed at Screening stage, Day 0, Day 1, Day 8-22, Day 23. Electrocardiogram monitoring will be assessed at Day 1, Day 8-22. Clinical laboratory tests will be assessed at Screening stage and Day 23. Electrocardiogram will be assessed at Screening stage, Day 0, Day 8-22 and Day 23 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ou Ning | First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
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| Drug |
|
| placebo | Drug |
|
| Day 0, Day 1, Day 8-22 and Day 23 |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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