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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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Tolvaptan oral administraction phase I PK clinical trial. Two groups of healthy male subjects. One group receives single dose of Tolvaptan. The other group receives multi dose of Tolvaptan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single dose | Experimental |
| |
| multi dose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| singe dose 15mg | Drug | succesfule screened subject, take single dose of 15mg Tolvaptan tablet with no feeding. |
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| Measure | Description | Time Frame |
|---|---|---|
| single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107 | peak concentration (Cmax) | Day 1 pre-dose and post-dose 0.5hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours |
| multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103 | peak concentration (Cmax) | Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point. |
| single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107 | time to peak (Tmax) | Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours |
| Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107 | area under the drug-time curve (AUC0-t and AUC0-∞) | Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours |
| single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107 | elimination half-life (t1/2) | Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours |
| single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107 | apparent clearance (CL/F) | Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41357896 | Derived | Liu H, Liu T, Liu M, Zheng X, Zhong W, Zhao Q, Jiang J, Hu P, Li Y. Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study. Front Pharmacol. 2025 Nov 21;16:1713702. doi: 10.3389/fphar.2025.1713702. eCollection 2025. |
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| single dose 30mg | Drug | succesfule screened subject, take single dose of 30mg Tolvaptan tablet with no feeding. |
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| single dose 60mg | Drug | succesfule screened subject, take single dose of 60mg Tolvaptan tablet with no feeding. |
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| single dose 120mg | Drug | succesfule screened subject, take single dose of 120mg Tolvaptan tablet with no feeding. |
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| multi dose 30mg | Drug | radomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 30mg Tolvaptan. First day, with no feeding, take single 30mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total. |
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| multi dose 60mg | Drug | radomize 24 healthy adult male to 2 groups, 12 subjects each. One group take 60mg Tolvaptan. First day, with no feeding, take single 60mg dose, then start from day 3rd, take medication for 7 days. 8 days treatment in total. |
|
| single dose Tolvaptan plasma pharmacokinetics, and its motablics DM-4103 and DM-4107 | apparent volume of distribution (Vd/F) | Day 1 pre-dose and post-dose 0.5 hour, 1 ,2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours |
| multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103 | time to peak (Tmax) | Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point |
| multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103 | area under the drug-time curve (AUC0-t and AUC0-∞) | Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point |
| multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103 | elimination half-life (t1/2) | Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point |
| multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103 | apparent clearance (CL/F) | Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point |
| multi dose Tolvaptan plasma pharmacokinetics and it's motablics DM-4107 and DM-4103 | apparent volume of distribution (Vd/F) | Day 1 & Day 9 at pre-dose, post-dose 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 (2nd and 10th day) and 48 (day 3rd and 11th). For other dosing day ( day 4 to 8) to collect at pre-dose( 24hr after last dose) point |