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The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of 1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research Center, and fasted for 10 hours overnight until administration. The medicine was swallowed with 240 ml water at room temperature. Blood samples were taken before administration and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the plasma. The plasma samples were divided into two aliquots and stored at -80 °C until bioanalysis. The half-life of levamlodipine is 30 ~ 50 hours. Washout period, the interval between two administration, is 21 days. In the two periods, the operation was kept the same.
Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour before taking the medicine. Other procedures were the same as those in the fasting group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine | Active Comparator | amlodipine reference formulation at a single dose of 10 mg |
|
| Levamlodipine | Experimental | levamlodipine test formulation at a single dose of 5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine 10 mg | Drug | The subjects randomly received single oral administration of amlodipine 10 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 64 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 | 64 days |
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 64 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 64 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 | Affiliation | Role |
|---|---|---|
| yu Cao, Doctor | the study director of phase I clinical research center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase â… Clinical Research Center | Qingdao | Shandong | 266003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33213527 | Derived | Li X, Wang C, Li T, Liu Y, Liu S, Tao Y, Ma Y, Gao X, Cao Y. Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: a single-dose and two-period crossover randomized study. BMC Pharmacol Toxicol. 2020 Nov 19;21(1):80. doi: 10.1186/s40360-020-00459-6. |
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The technical achievements (including but not limited to patent right and thesis publishing right) involved in this trial, clinical research materials and achievements are owned by Zhejiang onlycom Pharmaceutical Co., Ltd. With the written consent of Zhejiang onlycom Pharmaceutical Co., Ltd., all partners have the right to publish academic papers, and the Affiliated Hospital of Qingdao University, a clinical research institution, has the right to exchange research results in academic conferences or journals.
The data have been available on February 15, 2019. The duration has not been determined.
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| C542574 | levamlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Levamlodipine 5 mg | Drug | The subjects randomly received single oral administration of levamlodipine 5 mg. |
|
| 64 days |
| Incidence of abnormal temperature | Monitor the temperature | 64 days |
| Incidence of abnormal pulse | Temperature the pulse | 64 days |
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 64 days |