- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07608705
A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants
20. Mai 2026 aktualisiert von: Shandong Suncadia Medicine Co., Ltd.
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
This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
16
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Ying Wang
- Telefonnummer: +86-0518-82342973
- E-Mail: ying.wang.yw30@hengrui.com
Studienorte
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Qilu Hospital of Shandong University
-
Hauptermittler:
- Wei Zhao
-
Kontakt:
- Wei Zhao
- Telefonnummer: +86-0531-88382006
- E-Mail: Zhao4wei2@hotmail.com
-
Kontakt:
- Shuwen Yu
- Telefonnummer: +86-0531-82169349
- E-Mail: yaoxuebu2012@163.com
-
Hauptermittler:
- Shuwen Yu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 Tablets.
Atorvastatin Calcium tablets.
Midazolam oral solution.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: 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 the last quantifiable concentration (AUC 0-last)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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 the last quantifiable concentration (AUC0-last)
Zeitfenster: 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)
Zeitfenster: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to reach maximum observed concentration (Tmax)
Zeitfenster: 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.
|
|
Terminal elimination half-life (t1/2)
Zeitfenster: 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.
|
|
Apparent clearance (CL/F)
Zeitfenster: 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.
|
|
Apparent volume of distribution (Vz/F)
Zeitfenster: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Maximum observed plasma concentration (Cmax)
Zeitfenster: 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 the last quantifiable concentration (AUC 0-last)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
|
|
Apparent clearance (CL/F)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to 22 days.
|
Safety and Tolerability.
|
Up to 22 days.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
1. August 2026
Studienabschluss (Geschätzt)
1. August 2026
Studienanmeldedaten
Zuerst eingereicht
20. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Mai 2026
Zuerst gepostet (Tatsächlich)
27. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Stoffwechselerkrankungen
- Dyslipidämien
- Störungen des Fettstoffwechsels
- Ernährungs- und Stoffwechselerkrankungen
- Hyperlipidämien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Fettsäuren
- Lipide
- Azolen
- Benzazepines
- Pyrrolen
- Heptansäuren
- Benzodiazepine
- Atorvastatin
- Midazolam
Andere Studien-ID-Nummern
- HRS-1301-105
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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