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| Name | Class |
|---|---|
| Zibo Central Hospital | OTHER_GOV |
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The goal of this clinical trial] is to to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25 in healthy volunteers. The main questions it aims to answer are:
Participants will:
Take T25 under both fast and food state or mycapssa in under fast state in Day1, Day4, and Day7, 13. A follow-up visit is scheduled on D14+(7), which is 7~14 days after the last dose of investigational product via phone/message/WeChat or in face-to-face manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T25-Fast | Experimental | T25 administrated in fast state |
|
| T25 -Fed | Experimental | T25 administrated in fed state |
|
| mycapssa | Active Comparator | Mycapssa administrated in fast state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T25-Fast | Drug | Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state |
|
| Measure | Description | Time Frame |
|---|---|---|
| bioavailability | The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax) | From time 0 (administration) to 24 hours post-administration |
| bioavailability | The ratio of geometric least square means between the T25 and MYCAPSSA® for area under the concentration-time curve (AUC) from time zero to the last time point with a measurable concentration (AUC0-tlast) . Sampling (Fasted condition) occurs at the following timepoints: 0 (pre-dose) , 0.5 , 1.0, 1.33 , 1.67 , 2.0 , 2.33 , 2.67 , 3.0 , 3.33 , 3.67 , 4.0 , 4.5 , 5.0 , 5.5 , 6.0 , 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose. | From time 0 (administration) to 24 hours post-administration. |
| bioavailability | The ratio of geometric least square means between the T25 and MYCAPSSA® for AUC from time zero to infinity (AUC0-inf) via dose normalization. AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf) | From 0 (administration) to 24hour |
| bioavailability | The ratio of geometric least square means between the T25 under fed condition and under fasted condition for Cmax | From time 0 (administration) to 24 hours post-administration |
| bioavailability | The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC0-tlast (sampling occurs at the following timepoints: Fasted condition: 0 (pre-dose) , 0.5 , 1.0, 1.33, 1.67, 2.0, 2.33, 2.67, 3.0, 3.33, 3.67, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose; Fed condition: 0 (pre-dose), 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 , 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 , 11.0, 12.0, 14.0, 16.0, 24.0 hour post-dose;) |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile (Tlag) | the first observation with a measurable (non-zero) concentration (Tlag) | From time 0 (administration) to 24 hours post-administration |
| PK profile(Tmax) | time to reach maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Mycapssa | Drug | Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state |
|
| T25-Fed | Drug | Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state |
|
| From time 0 (administration) to 24 hours post-administration. |
| bioavailability | The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC from time zero to infinity (AUC0-inf).AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf) | From time 0 (administration) to 24hour. |
| From time 0 (administration) to 24 hours post-administration |
| PK profile(t₁/₂) | elimination half-life (t₁/₂) | From time 0 (administration) to 24 hours post-administration |
| PK profile(Kel) | elimination rate constant | From time 0 (administration) to 24 hours post-administration |
| PK profile(CL/F) | apparent total clearance after oral administration | From time 0 (administration) to 24 hours post-administration |
| PK profile(Vz/F) | apparent volume of distribution after oral administration | From time 0 (administration) to 24 hours post-administration |
| PK profile(AUC_%Extrap) | percentage of area under the concentration-time curve extrapolated beyond the last measurable concentration | From time 0 (administration) to 24 hours post-administration |
| the gastrointestinal transit of T25 using an abdominal X-ray | the abdominal X-ray | Administration of T25 under fasted condition: the abdominal X-ray will be taken at 0.75 hour, 1.5 hour, 2.0 hour, 3.0 hour, 4.0 hour post-dose. |
| the gastrointestinal transit of T25 using an abdominal X-ray | the abdominal X-ray | Administration of T25 under fed condition: the abdominal X-ray will be taken at 2.0 hour, 3.0 hour, 4.5 hour, 6.0 hour, 8.0hour post-dose. |
| Safety and tolerability - number and severity of adverse events | Incidence and severity of AE | From the first dose until 7 days after the last dose |
| Safety and tolerability -Temperature (ear) | Incidence of Adverse Events and Abnormalities as assessed by Temperature (ear) | From the first dose until 7 days after the last dose |
| Safety and tolerability - Blood pressure | Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure) | From the first dose until 7 days after the last dose |
| Safety and tolerability -Pulse | Incidence of Adverse Events and Abnormalities as assessed by pulse | From the first dose until 7 days after the last dose |
| Safety and tolerability - Physical examination | Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination | From the first dose until 7 days after the last dose |
| Safety and tolerability - clinical laboratory tests | Number of abnormalities assessed based on safety bloods and urine test( hematology, blood biochemistry, coagulation function, urinalysis, thyroid function, serum vitamin B12, serum pregnancy test (only for females), etc) | From the first dose until 7 days after the last dose |
| Safety and tolerability - ECG | Heart Rate, PR Interval, QRS duration,QT Interval,QTc Interval | From the first dose until 7 days after the last dose |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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