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A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moxifloxacin, pill | Experimental | Oral dose of 400mg moxifloxacin |
|
| moxifloxacin-placebo,pill | Placebo Comparator | A pill of moxifloxacin-placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin | Drug | oral dose of 400mg moxifloxacin |
|
| Measure | Description | Time Frame |
|---|---|---|
| baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate, PR, QRS, QTcB and QTcI | 1 month |
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Inclusion Criteria:
Healthy Chinese subjects, male, 20 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
At Screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for 5 minutes. All of vital signs should be within normal ranges:
Body weight need to be at least 50kg or above, 19kg/m2≤ Body Mass Index(BMI) ≤25kg/m2
Be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent prior to any screening procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingchuan Guo, MD | Contact | 861082265509 | guojingchuan1029@126.com | |
| Haiyan Li, MD | Contact | 861082266226 | haiyanli1027@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiyan Li, MD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital Drug Clinical Trial Center | Recruiting | Beijing | 100191 | China |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| moxifloxacin-placebo | Drug | Oral dose of a pill of moxifloxacin-placebo |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |