A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants
An Open-label, Single-arm, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HRS-1301 Tablets on the Pharmacokinetics of Midazolam and Atorvastatin Calcium Tablets in Healthy Participants
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Ying Wang
- Telefonnummer: +86-0518-82342973
- E-post: ying.wang.yw30@hengrui.com
Studiesteder
-
-
Shandong
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Jinan, Shandong, Kina, 250012
- Rekruttering
- Qilu Hospital of Shandong University
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Hovedetterforsker:
- Wei Zhao
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Ta kontakt med:
- Wei Zhao
- Telefonnummer: +86-0531-88382006
- E-post: Zhao4wei2@hotmail.com
-
Ta kontakt med:
- Shuwen Yu
- Telefonnummer: +86-0531-82169349
- E-post: yaoxuebu2012@163.com
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Hovedetterforsker:
- Shuwen Yu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Subjects must be aged ≥ 18 years and ≤ 55 years on the day of signing the informed consent form (ICF);
- At screening, body mass index (BMI) must be ≥ 19.0 kg/m² and < 28 kg/m², with body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females;
- Physical examination, vital signs, electrocardiogram (ECG), posteroanterior and lateral chest X-ray/CT, abdominal ultrasound, and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and thyroid function) were normal or abnormal but of no clinical significance;
- Female participants must not be pregnant or lactating and must have negative pregnancy test results prior to investigational drug administration; participants must have had no unprotected sexual intercourse within two weeks prior to screening; female participants of childbearing potential and male participants with partners of childbearing potential must agree to comply with the contraception requirements for the duration specified in the protocol and have no plans to donate sperm or eggs;
- Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF).
Exclusion Criteria:
- Subjects with previous medical history or current diagnosis of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, infectious, immunological, malignant neoplastic, neurological, or psychiatric/metabolic disorders/dysfunctions, or any other disease;
- Subjects who have gastrointestinal, hepatic, renal, or other known diseases that may affect drug absorption, distribution, metabolism, or excretion, or that may reduce compliance;
- Subjects who have experienced severe trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial period;
- Subjects with a history of specific allergies, or with an allergic constitution, or with known hypersensitivity to any component of the investigational drug;
- Subjects who have used any medication within 2 weeks prior to screening, or who are still within 5 half-lives of any medication at the time of screening;
- Subjects who have participated in any other clinical trial of a drug or medical device within 3 months prior to screening, or who are still within 5 half-lives of a prior investigational drug at the time of screening;
- Subjects who have donated blood ≥ 200 mL or experienced significant blood loss (≥ 400 mL) within 4 weeks prior to screening, or who have received a blood transfusion within 8 weeks prior to screening;
- Subjects who have received a live (attenuated) vaccine within 4 weeks prior to screening or plan to receive such a vaccine during the trial period.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: HRS-1301 and Midazolam or Atorvastatin Group
HRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days.
|
HRS-1301 tabletter.
Atorvastatin Calcium tablets.
Midazolam oral solution.
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum observed plasma concentration (Cmax)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Maximum observed plasma concentration (Cmax)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to reach maximum observed concentration (Tmax)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Terminal elimination half-life (t1/2)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
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Apparent clearance (CL/F)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
|
Apparent volume of distribution (Vz/F)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
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Maximum observed plasma concentration (Cmax)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
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Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Tidsramme: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Apparent volume of distribution (Vz/F)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
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Up to 18 days.
|
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Apparent clearance (CL/F)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Time to reach maximum observed concentration (Tmax)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Terminal elimination half-life (t1/2)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Maximum observed plasma concentration (Cmax)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Tidsramme: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Incidence and severity of adverse events (AEs)
Tidsramme: Up to 22 days.
|
Safety and Tolerability.
|
Up to 22 days.
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
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
- Metabolske sykdommer
- Dyslipidemier
- Lipidmetabolismeforstyrrelser
- Ernæringsmessige og metabolske sykdommer
- Hyperlipidemier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Fettsyrer
- Lipider
- Azoler
- Benzazepiner
- Pyrroles
- Heptansyrer
- Benzodiazepiner
- Atorvastatin
- Midazolam
Andre studie-ID-numre
Andre studie-ID-numre
- HRS-1301-105
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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