En bioækvivalensundersøgelse af to formuleringer af HRS-1893-tabletter hos raske deltagere
En bioekvivalensundersøgelse af to formuleringer af HRS-1893-tabletter hos raske deltagere
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Beijing Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subjects aged 18 to 55 years (inclusive), regardless of gender;
- Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥ 50.0 kg and < 90.0 kg for men, and ≥ 45.0 kg and < 90.0 kg for women;
- No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment;
- No clinically significant abnormalities on the 12-lead ECG;
- The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
Exclusion Criteria:
- Subjects with suspected hypersensitivity to the investigational drug or any excipient;
- The subject has a history of syncope;
- Exclusion due to blood pressure: Systolic Blood Pressure (SBP) >140 mmHg or <90 mmHg; OR Diastolic Blood Pressure (DBP) >90 mmHg or <60 mmHg, as determined by the investigator to be clinically significant;
- History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption;
- A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag);
- Subjects who meet any of the following criteria will be excluded: a. Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening; b. Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits); c. Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration; d. Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse;
- History of substance abuse;
- Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded;
- Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: HRS-1893 testformuleringsgruppe
|
Test formulation of HRS-1893 tablet, oral. |
|
Eksperimentel: HRS-1893 referenceformuleringsgruppe
|
Reference formulation of HRS-1893 tablet, oral. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak concentration (Cmax).
Tidsramme: From Day 1 to Day 17.
|
Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Area under the plasma concentration - time curve from Time 0 to the last quantifiable time point (AUC0-t).
Tidsramme: From Day 1 to Day 17.
|
Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Area under the plasma concentration - time curve from Time 0 to infinity (AUC0-∞).
Tidsramme: From Day 1 to Day 17.
|
Primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to peak concentration (Tmax).
Tidsramme: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Elimination half-life (t1/2).
Tidsramme: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Apparent clearance (CL/F).
Tidsramme: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Apparent volume of distribution (Vz/F).
Tidsramme: From Day 1 to Day 17.
|
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 17.
|
|
Incidence and severity of any adverse events (AEs).
Tidsramme: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
|
12-Lead Electrocardiogram (ECG) QT Interval.
Tidsramme: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
|
Transthoracic echocardiogram (TTE) results.
Tidsramme: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
|
Vital signs results - blood pressure.
Tidsramme: From Day 1 to Day 21 ± 2.
|
Safety and tolerability of different HRS-1893 formulations in healthy subjects. |
From Day 1 to Day 21 ± 2.
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HRS-1893-108
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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