- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02354027
The Drug-drug Interaction of SHR3824 and Metformin
14. juli 2015 opdateret af: Jiangsu HengRui Medicine Co., Ltd.
Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.
Studieoversigt
Detaljeret beskrivelse
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and metformin in healthy adult volunteers.
SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM.
SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8.
Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
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
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 24 kg/m2.
Exclusion Criteria:
- History of diabetes
- History of heart failure or renal insufficiency
- Urinary tract infections, or vulvovaginal mycotic infections
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- Known allergy to SHR3824 or metformin or any of the excipients of the formulation of SHR3824 or metformin
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: SHR3824 25mg/metformin 1000mg
Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8.
|
Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8. Drug: SHR3824 + Metformin
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The maximum plasma concentration (Cmax) of SHR3824.
Tidsramme: At protocol-specified times up to Day 9.
|
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
|
At protocol-specified times up to Day 9.
|
The area under the plasma concentration-time curve (AUC) of SHR3824.
Tidsramme: At protocol-specified times up to Day 9.
|
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
|
At protocol-specified times up to Day 9.
|
The maximum plasma concentration (Cmax) of metformin.
Tidsramme: At protocol-specified times up to Day 9.
|
Cmax (a measure of the body's exposure to metformin) will be compared.
before and after administration of multiple doses of SHR3824
|
At protocol-specified times up to Day 9.
|
The area under the plasma concentration-time curve (AUC) of metformin
Tidsramme: At protocol-specified times up to Day 9.
|
AUC (a measure of the body's exposure to metformin) will be compared before and after administration of multiple doses of SHR3824.
|
At protocol-specified times up to Day 9.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The number of volunteers with adverse events as a measure of safety and tolerability.
Tidsramme: Up tp day 9.
|
Up tp day 9.
|
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
1. september 2014
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først indsendt
29. januar 2015
Først indsendt, der opfyldte QC-kriterier
29. januar 2015
Først opslået (Skøn)
3. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SHR3824-105
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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