En bioekvivalensstudie av to formuleringer av HRS-1893-tabletter hos friske deltakere
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Faktiske)
Registrering
Fase
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Beijing Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: HRS-1893 testformuleringsgruppe
|
Test formulation of HRS-1893 tablet, oral. |
|
Eksperimentell: HRS-1893 referanseformuleringsgruppe
|
Reference formulation of HRS-1893 tablet, oral. |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Faktiske)
Primær fullføring
Studiet fullført (Faktiske)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- HRS-1893-108
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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