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According to the relevant provisions of bioequivalence test, nifedipine sustained-release tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg / tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy subjects under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Release Nifedipine Tablets(Adalat® GITS) | Active Comparator | Extended Release Nifedipine reference formulation at a single dose of 30 mg |
|
| Extended Release Nifedipine Tablets | Experimental | Extended Release Nifedipine test formulation at a single dose of 30 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Release Nifedipine Tablets 30 mg | Drug | The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 60 days |
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 60 days |
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 60 days |
| Incidence of abnormal blood pressure | Monitor both systolic and diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao | Contact | +86 18661809090 | caoyu1767@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Research Center | Recruiting | Qingdao | Shandong | 266003 | China |
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| Extended Release Nifedipine Tablets 30 mg (Adalat® GITS) | Drug | The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg. |
|
| 60 days |
| Incidence of abnormal temperature | Monitor the temperature | 60 days |
| Incidence of abnormal pulse | Temperature the pulse | 60 days |
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 60 days |