- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04156685
Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1
6. november 2019 opdateret af: Chong Kun Dang Pharmaceutical
An Open-label, Rendomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-387 in Healthy Subjects.
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-387
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-387 in helalthy subjects.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
58
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Seongbuk-Gu
-
Seoul, Seongbuk-Gu, Korea, Republikken
- Korea University Anam Hospital
-
-
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
19 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adult older than 19 years and less than 45 years at the time of screening.
- BMI 18.5~29.9 kg/m2 and body weight more than 50kg.
- Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to one months after the last investigational product and not to provide sperm for men.
- Subjects who sign on an informed consent form willingly.
Exclusion Criteria:
- Subjects who have a clinically significant disease or medical history such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nervous and mental disease.
- Subjects who have acute disease within 28 days prior to the first administration.
- Subjects who have history that may affect the ADME.
- Subjects who have medical history or medical abuse history of hypersensitivity from SGLT inhibitors or Biguanides including Metformin or other medications(Aspirin, Antibiotics etc.).
- Subjects who have clinically significant chronic disease.
- Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption.
Subjects whose laboratory test result are same as below;
- AST,ALT > UNL(Upper Normal Limit)x3
- Fasting glucose level out of 70-125mg/dl
- Creatinine clearance is lower than 80mL/min which is calcuated by Cockcroft-Gault formulation.
- QT>450msec
- Positive urine hCG(female).
Subjects whoes blood pressure exceeds out of normal range as below at screening.
- SBP : over 100mmHg, under 160mmHg
- DBP : over 60mmHg, under 100mmHg
- Subjects who have been found to be positive in serological tests(HBs antigen, HCV antibody and HIV antibody).
- Subjects who took ETC(Ethical Drug), oriental medicine within 2 weeks prior to the first administration of investigational products.
- Subjects who took OTC(Over-the-counter Drug, including korean galenical drug) within 10 days prior to the first administration of investigational products.
- Subjects who have allergic disease which has clinical significance(But, light allergic rhinitis and ligth allergic dermatitis which do not need medication is exceptional).
- Subjects who can not eat standard meals provided by the institution.
- Subjects who donated whole blood within 60 days, donated the blood components within 20 days prior to the first administration of investigational products.
- Subjects who received blood transfusion within 30 days prior to the first administration of investigational products.
- Subjects who were participated in the other clinical trial within 90 days prior to the first administration of investigational products.
- Subjects who took medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 6months prior to the first administration of investigational products.
- Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days prior to the first administration of investigational products. (Ingestion of grapefruit juice>1L/day or Caffein>5Cups/day).
- Subjects who have took regular alcohol(alcohol>30g/day) prior to the first administration of investigational products.
- Subjects who smoked more than 10 cigarettes per day prior 3months to the first administration of investigational products or cannot discontinue smoking during the clinical trial.
- Subjects who is determined unsuitable to participate in this clinical trial by the investigator.
- Lactating Women.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: PartA, Treatment-1
Period 1 : Reference drug Period 2 : Test drug
|
Once a day.
Under fasting condition
Andre navne:
|
Eksperimentel: PartA, Treatment-2
Period 1 : Test drug Period 2 : Reference drug
|
Once a day.
Under fasting condition
Andre navne:
|
Eksperimentel: PartB, Treatment-1
Period 1 : Reference drug Period 2 : Test drug
|
Once a day.
Under fed condition
Andre navne:
|
Eksperimentel: PartB, Treatment-2
Period 1 : Test drug Period 2 : Reference drug
|
Once a day.
Under fed condition
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Part A : Cmax under fasting condition
Tidsramme: 0(predose)~48 hours
|
Maximum concentration of the dapagliflozin
|
0(predose)~48 hours
|
Part A : Cmax under fasting condition
Tidsramme: 0(predose)~48 hours
|
Maximum concentration of the metformin
|
0(predose)~48 hours
|
Part A : AUClast under fasting condition
Tidsramme: 0(predose)~48 hours
|
Area Under Curve(last) of the dapagliflozin
|
0(predose)~48 hours
|
Part A : AUClast under fasting condition
Tidsramme: 0(predose)~48 hours
|
Area Under Curve(last) of the metformin
|
0(predose)~48 hours
|
Part B : Cmax under fed condition
Tidsramme: 0(predose)~48 hours
|
Maximum concentration of the metformin
|
0(predose)~48 hours
|
Part B : AUClast under fed condition
Tidsramme: 0(predose)~48 hours
|
Area Under Curve(last) of the metformin
|
0(predose)~48 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Part A : AUCinf under fasting condition
Tidsramme: 0(predose)~48 hours
|
Area Under Curve(infinit) of the dapagliflozin
|
0(predose)~48 hours
|
Part A : AUCinf under fasting condition
Tidsramme: 0(predose)~48 hours
|
Area Under Curve(infinit) of the metformin
|
0(predose)~48 hours
|
Part A : Tmax under fasting condition
Tidsramme: 0(predose)~48 hours
|
Time of maximum concentration of the dapagliflozin
|
0(predose)~48 hours
|
Part A : Tmax under fasting condition
Tidsramme: 0(predose)~48 hours
|
Time of maximum concentration of the metformin
|
0(predose)~48 hours
|
Part A : t1/2 under fasting condition
Tidsramme: 0(predose)~48 hours
|
Half life of the dapagliflozin
|
0(predose)~48 hours
|
Part A : t1/2 under fasting condition
Tidsramme: 0(predose)~48 hours
|
Half life of the metformin
|
0(predose)~48 hours
|
Part B : AUCinf under fed condition
Tidsramme: 0(predose)~48 hours
|
Area Under Curve(infinit) of the metformin
|
0(predose)~48 hours
|
Part B : Tmax under fed condition
Tidsramme: 0(predose)~48 hours
|
Time of Maximum concentration of the metformin
|
0(predose)~48 hours
|
Part B : t1/2 under fed condition
Tidsramme: 0(predose)~48 hours
|
Half life of the metformin
|
0(predose)~48 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ji-Young Park, M.D, Ph.D, Korea University Anam Hospital / Seoul, Seongbuk-Gu, South Korea
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)
6. august 2019
Primær færdiggørelse (Faktiske)
30. august 2019
Studieafslutning (Faktiske)
2. oktober 2019
Datoer for studieregistrering
Først indsendt
6. november 2019
Først indsendt, der opfyldte QC-kriterier
6. november 2019
Først opslået (Faktiske)
7. november 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A84_07BE1908
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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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