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The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.
The main questions it aims to answer are:
Participants in sequence A will receive oral administration of 50 mg TLL-018 extended-release tablet once on day 1 for the first cycle, and then continue to receive the same dosage once daily for 5 consecutive days from day 3. After a 3-day washout period, they will enter the second cycle and will receive one oral dose of 20 mg TLL-018 immediate-release tablet in the morning of day 11, followed by a second dose of 20 at night 12 hours later, then continued to receive 20 mg TLL-018 twice daily for 5 consecutive days from day 13. Hospital observation for 3 days after taking the medication..
Participants in sequence B will receive 20 mg TLL-018 immediate-release tablet in the first cycle and 50 mg TLL-018 extended-release tablet in the second cycle, with the same medication pattern as those in sequence A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequence A | Experimental | In cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. |
|
| sequence B | Experimental | In cycle 1, subjects in sequence B receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning on day 1 and another dose 12 hours later at night. From day 3 onward, they continue to receive 20-mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. After 3 days of washout, subjects receive a 50-mg single dose of TLL-018 extended-release tablet on day 11 In cycle 2, and once daily for 5 consecutive days from day 13 onwards. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLL-018 extended-release tablet | Drug | 50mg TLL-018 extended-release tablet QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose: AUC0-t | Area under the blood concentration-time curve from time 0 to the last measurable time t after dosing | Screening up to Day 17 |
| Single Dose: AUC0-∞ | Area under the blood concentration-time curve from time 0 to infinity after dosing | Screening up to Day 17 |
| stable state: AUC0-24 | Area under the blood concentration-time curve from time 0 to 24 hours after dosing | Screening up to Day 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 318000 | China |
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Eligible subjects screened will be randomly assigned to sequence A and sequence B in a 1:1 ratio. In cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. The subjects will be hospitalized for observation for 3 days after the end of medication.
Subjects randomly assigned to sequence B received 20 mg of TLL-018 immediate-release tablets in cycle 1 and 50 mg extended-release tablet in cycle 2. The medication pattern was consistent with that of the subjects in sequence A. All the subjects took medicine after meal.
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| TLL-018 immediate-release tablet | Drug | 20mg TLL-018 immediate-release tablet BID |
|
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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