- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04667156
Study to Investigate Relative Bioavailability of Different Formulations of SHR6390 in Healthy Subjects
11. oktober 2021 oppdatert av: 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
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Hubei
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Wuhan, Hubei, Kina, 470071
- Zhongnan Hospital of Wuhan University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Execute an informed consent;
- Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
- 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);
- 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;
- 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:
- 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;
- Patients who have received any previous operation affecting gastrointestinal absorption;
- Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
- Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
- HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;
- History of drug use or drug abuse, or drug screening positive;
- Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
- Allergic constitution, including severe drug allergy or drug allergy history; known allergy to shr6390 tablets or its excipients;
- Having swallowing resistance or disorder, affecting drug absorption;
- Participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
- Inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C8 were taken within 4 weeks before the first administration of study drug;
- 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;
- 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;
- Lactating women;
- The researchers considered that the subjects had any other factors that were not suitable for the trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
|
Eksperimentell: 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
|
Eksperimentell: 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
|
Eksperimentell: 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
|
Eksperimentell: 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
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fr
Tidsramme: Day1~Day35
|
Relative bioavailability of the two new formulations on SHR6390
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Day1~Day35
|
Cmax
Tidsramme: Day1~Day35
|
Maximum concentration of SHR6390
|
Day1~Day35
|
AUC0-t
Tidsramme: Day1~Day35
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. desember 2020
Primær fullføring (Faktiske)
29. januar 2021
Studiet fullført (Faktiske)
29. januar 2021
Datoer for studieregistrering
Først innsendt
2. desember 2020
Først innsendt som oppfylte QC-kriteriene
9. desember 2020
Først lagt ut (Faktiske)
14. desember 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. oktober 2021
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- SHR6390-I-112
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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