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Primary objective: To evaluate the effect of rabeprazole on the pharmacokinetics of TQ05105 tablets.
Secondary objective: To assess the safety and tolerability of single oral administration of TQ05105 tablets alone and in combination with rabeprazole in healthy study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ05105 tablets | Other | TQ05105 tablets combined with rabeprazole sodium enteric-coated tablets, 14 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 tablets | Drug | TQ05105 tablets are Janus kinase (JAK) inhibitors. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Maximum plasma drug concentration. | 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Area under the plasma concentration-time curve ( AUC0-t) | The area enclosed by the blood concentration curve to the timeline. | 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Tmax) | The time required to reach peak concentration after administration. | 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Plasma clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoping Yang, Doctor | Contact | 0731-89918665 | ygp9880@163.com | |
| Xiaocong Zuo, Doctor | Contact | 13808466377 | zuoxc08@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital, Central South University | Changsha | Hunan | 410013 | China |
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| Rabeprazole sodium enteric-coated tablets |
| Drug |
Rabeprazole sodium enteric-coated tablets. |
|
How much of the plasma is cleared per unit of time.
| 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Plasma elimination half-life (t1/2) | The time it takes for the terminal phase blood concentration to drop by half. | 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Area under the plasma concentration-time curve ( AUC0-∞) | The area enclosed by the blood concentration curve to the timeline. | 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Adverse event rate | The occurrence of all adverse events (AEs), and serious adverse events (SAEs). | 14 days after the first dose |
| Hematology | Abnormal hematology | 14 days after the first dose |
| Serum biochemistry | Abnormal serum biochemistry | 14 days after the first dose |
| Coagulation | Abnormal coagulation | 14 days after the first dose |
| Urinalysis | Abnormal urinalysis | 14 days after the first dose |
| Blood pressure | Abnormal blood pressure | 14 days after the first dose |
| Pulse | Abnormal pulse | 14 days after the first dose |
| Respiration | Abnormal respiration | 14 days after the first dose |
| Body temperature | Abnormal body temperature | 14 days after the first dose |
| 12-lead ECG | Abnormal 12-lead ECG | 14 days after the first dose |
| Physical examination | Abnormal physical examination | 14 days after the first dose |
| Symptoms | Abnormal symptoms | 14 days after the first dose |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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