Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers

20. mai 2020 oppdatert av: AnewPharma

A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of CM082 Tablet.

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet in Chinese Healthy Volunteers. In addition, the safety of CM082 tablet in Chinese Healthy Volunteers who with High-fat meal or fasting state will also be evaluated.

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

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 311009
        • The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College

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:

  • age: 18 - 45 years;
  • sex: male and female;
  • body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);
  • Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;
  • Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available;
  • Written informed consent;

Exclusion Criteria:

  • Received any investigational drugs within 14 days before the screening test;
  • Donated 200 mL of whole blood within 30 days before the screening test,or donated 200 mL of whole blood during the study or within 30 days after completion of the study;
  • Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;
  • History of drug or food allergies;
  • Abnormal blood pressure or pulse,Abnormal laboratory tests;
  • Participated in other clinical trials within 3 months before screening;
  • Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;
  • Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;
  • Clinically apparent disease/infection within 1 month before screening;
  • The researchers determined that there were other conditions 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: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Period 1: fasted control → Period 2: fed control
Period 1: administration of CM082 200 mg at 7:30am, without the breakfast;Period 2: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast
The two groups of subjects were given an equal dose of CM082 tablet (200 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of CM082.
Eksperimentell: Period 1: fed control → Period 2: fasted control
Period 1: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast;Period 2: administration of CM082 200 mg at 7:30am, without the breakfast
The two groups of subjects were given an equal dose of CM082 tablet (200 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of CM082.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peak plasma concentration (Cmax) of CM082
Tidsramme: pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)
The effect of food on Cmax after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)
Area under the plasma concentration versus time curve (AUC) of CM082
Tidsramme: pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)
The effect of food on AUC after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)
Time of maximum concentration(Tmax)of CM082
Tidsramme: pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)
The effect of food on Tmax after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)
Half life(T1/2)of CM082
Tidsramme: pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)
The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions
pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of adverse events
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months
Percentage of adverse events as assessed by CTCAE v4.03
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studiestol: zourong ruan, The Second Affiliated Hospital of Zhejiang University Medical College

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)

19. desember 2019

Primær fullføring (Faktiske)

16. januar 2020

Studiet fullført (Faktiske)

16. januar 2020

Datoer for studieregistrering

Først innsendt

11. oktober 2019

Først innsendt som oppfylte QC-kriteriene

11. oktober 2019

Først lagt ut (Faktiske)

15. oktober 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CM082-CA-I-106

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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. .

Abonnere