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A randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and Chia Tai Tianqing Pharmaceutical Group Co., Ltd, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib malate capsules generic product | Experimental | Single dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively. |
|
| Sunitinib malate capsules reference product | Active Comparator | Single dose of Sunitinib malate capsule under fed condition on Day 1 and Day 29, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib malate capsules generic product | Drug | Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Maximum plasma concentration | Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
| Time to maximum concentration (Tmax) | Time to reach maximum concentration after drug administration | Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
| Area under the drug-time curve (AUC) | Area under the drug-time curve | Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
| Apparent terminal elimination half-life (t1/2) | Apparent terminal elimination half-life (t1/2) | Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution | Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
| Clearance rate (CL/F) | Clearance rate | Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
| Apparent terminal elimination rate constant (λz) | Apparent terminal elimination rate constant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) | Incidence of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) V5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Severity of adverse events (AE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D002292 | Carcinoma, Renal Cell |
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sunitinib malate capsules reference product | Drug | Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK). |
|
| Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
| Relative bioavailability (F) | Relative bioavailability (F) of the tested product to reference product | Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration. |
Severity of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. |
| From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal blood biochemistry results | The proportion of subjects with abnormal blood biochemistry results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal blood routine | The proportion of subjects with abnormal blood routine results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal urinalysis results | The proportion of subjects with abnormal urinalysis results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal coagulation function | The proportion of subjects with abnormal coagulation function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal thyroid function | The proportion of subjects with abnormal thyroid function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal blood pressure | The proportion of subjects with abnormal blood pressure evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal pulse | The proportion of subjects with abnormal pulse evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal body temperature | The proportion of subjects with abnormal body temperature evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| Proportion of subjects with abnormal 12-lead electrocardiogram (ECG) | The proportion of subjects with abnormal 12-lead ECG evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0. | From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days. |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000236 | Adenoma |
| D010190 | Pancreatic Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |