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Background: The current study is a randomized, open-label, two-period, two-sequence, two-way crossover pharmacokinetic study in healthy Jordanian subjects to evaluate the pharmacokinetics and bioequivalence profile of two formulations of empagliflozin 10-mg under fasting and fed conditions administered orally.; (2) Methods: The plasma concentrations of empagliflozin were determined using High-performance liquid chromatography- Mass Spectrometry/ Mass Spectrometry (HPLC-MS/MS) method. This study included 26 subjects, 26 in each fasting and fed group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting state | Active Comparator |
| |
| Fed state | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 mg Tab | Drug | The Empagliflozin 10 mg Tab were administered orally. The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method. Tolerability and safety were assessed throughout the study. This study included 26 subjects, 26 in each fasting and fed group. |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method. | The plasma concentration of empagliflozin under fasting and fed conditions states were measured using HPLC-MS/MS method and recorded in nmol\L. | 5 months |
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Inclusion Criteria:
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wael Abu Dayyih | Amman | None Selected | 11196 | Jordan |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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