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Study to Investigate Relative Bioavailability of Different Formulations of SHR6390 in Healthy Subjects

11. oktober 2021 opdateret af: Jiangsu HengRui Medicine Co., Ltd.

A Single-centre, Single Dose, Randomized, Open-label, Three Period, Six Sequence, Cross Controlled Study to Assess the Relative Bioavailability of the New and Traditional Formulations on SHR6390 in Healthy Subjects

The purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Hubei
      • Wuhan, Hubei, Kina, 470071
        • Zhongnan Hospital of Wuhan University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Execute an informed consent;
  2. Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
  3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
  4. Physical examination, vital signs, laboratory examination , 12-Lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
  5. Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 7 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 72 hours before the first administration of the study drug should be negative.

Exclusion Criteria:

  1. Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
  2. Patients who have received any previous operation affecting gastrointestinal absorption;
  3. Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
  4. Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
  5. HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;
  6. History of drug use or drug abuse, or drug screening positive;
  7. Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
  8. Allergic constitution, including severe drug allergy or drug allergy history; known allergy to shr6390 tablets or its excipients;
  9. Having swallowing resistance or disorder, affecting drug absorption;
  10. Participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
  11. Inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C8 were taken within 4 weeks before the first administration of study drug;
  12. Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
  13. Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 72 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
  14. Lactating women;
  15. The researchers considered that the subjects had any other factors that were not suitable for the trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence 1
Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 traditional formulation (R) in the last period
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Eksperimentel: Sequence 2
Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 new formulation 2 (T2) in the last period
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Eksperimentel: Sequence 3
Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 1 (T1) in the last period
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Eksperimentel: Sequence 4
Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 2 (T2) in the last period
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Eksperimentel: Sequence 5
Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 traditional formulation (R) in the last period
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Eksperimentel: Sequence 6
Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 new formulation 1 (T1) in the last period
SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fr
Tidsramme: Day1~Day35
Relative bioavailability of the two new formulations on SHR6390
Day1~Day35
Cmax
Tidsramme: Day1~Day35
Maximum concentration of SHR6390
Day1~Day35
AUC0-t
Tidsramme: Day1~Day35
Area under the concentration-time curve from time zero to time t of SHR6390
Day1~Day35
AUC0-∞
Tidsramme: Day1~Day35
Area under the concentration-time curve extrapolated to infinity of SHR6390
Day1~Day35

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. december 2020

Primær færdiggørelse (Faktiske)

29. januar 2021

Studieafslutning (Faktiske)

29. januar 2021

Datoer for studieregistrering

Først indsendt

2. december 2020

Først indsendt, der opfyldte QC-kriterier

9. december 2020

Først opslået (Faktiske)

14. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SHR6390-I-112

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Kliniske forsøg med SHR6390

Abonner