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| Name | Class |
|---|---|
| Hainan Linheng Pharmaceutical Co., Ltd. | UNKNOWN |
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The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers.
The trial preparation is Calcium Hydroxybenzene Sulphonate Dispersible Tablets produced by Hainan Linheng Pharmaceutical Co., Ltd.
The reference preparation is Calcium Hydroxybenzene Sulphonate Tablets (Doxium ®) produced by OM pharma S.A.
The bioequivalence of two preparations will be evaluated at the fast or fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Hydroxybenzene Sulphonate Dispersible Tablets | Experimental | The healthy subjects will be administered a single dose of Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g under fast or fed conditions. |
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| Doxium® | Active Comparator | The healthy subjects will be administered a single dose of Doxium® 250mg under fast or fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g | Drug | A generic product manufactured by Hainan Linheng Pharmaceutical Co., Ltd. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on Cmax | Cmax - Maximum Observed Concentration in Plasma | Pharmacokinetic plasma samples collected over 36 hour period |
| Bioequivalence based on AUC 0-t | Area Under the Concentration-time Curve From Time Zero to Time of Last | Pharmacokinetic plasma samples collected over 36 hour period |
| Bioequivalence based on AUC 0-∞ | Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Pharmacokinetic plasma samples collected over 36 hour period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wu, Dr | Contact | 0086-10-58268486 | trdrug@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institue for Drug Clinical Trials | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Calcium Hydroxybenzene Sulfonate Tablets(Doxium®) 250mg | Drug | Calcium Hydroxybenzene Sulfonate Tablets(Doxium®)produced by OM pharma S.A. |
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