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A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers

8 januari 2020 bijgewerkt door: Chong Kun Dang Pharmaceutical

Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers

The purpose of this study is to evaluate the pharmacokinetics and Safety/Tolerability of CKD-386

Studie Overzicht

Gedetailleerde beschrijving

Phase I clinical trial to compare the pharmacokinetics and tolerability of CKD-386 with co-administration of D012, D326, and D337 in healthy adult volunteers

Studietype

Ingrijpend

Inschrijving (Verwacht)

30

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Those who are over 19 years old at the screening visit
  2. Those who weigh more than 50kg (45kg or more for women) at the screening visit and have a body mass index (BMI) within the range of 18-30kg/m^2
  3. Those who meet the following conditions of blood pressure measured in a sitting position after sufficient rest at the screening visit

    • Systolic blood pressure: 90mmHg or more and 139mmHg or less
    • Diastolic blood pressure: 60mmHg or more and 89mmHg or less
  4. Those who no congenital or chronic disease based on screening and no pathological symptoms or findings in medical examination results (e.g. EEG, ECG, chest and gastroscopy or gastrointestinal radiographs, if necessary)
  5. The person in charge of the examination (or authorized test physician) who has determined that the test subject is suitable for the diagnostic test and electrocardiogram test such as hematology test, blood chemistry test, serology test and urine test performed according to the characteristics of the investigational drug product
  6. Persons agreeing to exclude the possibility of pregnancy using appropriate contraceptive methods and not providing sperm or eggs from the date of first administration of the investigational drug to the 14th day after the last administration of the investigational drug

Exclusion Criteria:

  1. Those who participated in other clinical trials (including bioequivalence studies) within 6 months before the first dose and received the investigational drug
  2. Those who used drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within one month before the first dose, or who used drugs that may interfere with this test within 10 days before the first dose
  3. Those who have donated whole blood within 2 months before the first dose or component donation within 1 month, or have transfused within 1 month
  4. Those who have had a history of gastrointestinal resection that may affect the absorption of the investigational drug (except appendectomy and hernia surgery)
  5. A person who meets the following conditions within one month before the first administration date

    • Excess alcohol: 21 cups / week for men and 14 cups / week for women.

      [1 glass = 50 mL of shochu or 30 mL of liquor or 250 mL of beer]

    • Smokers exceeding 20 cigarettes per day
  6. Patients with the following diseases

    • Patients with hypersensitivity to the main constituents or components of the investigational drug
    • Severe hepatic impairment, biliary atresia or cholestasis
    • Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
    • Diabetes mellitus
    • Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
    • Renal vascular hypertension patients
    • Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
    • Patients with myopathy or have a history of family or genetic history of myopathy
    • Hypothyroidism
    • If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
  7. Genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
  8. person who is considered to be unsuitable for participation in this clinical trial for reasons other than the above selection / exclusion criteria.
  9. In the case of female volunteers, the suspected or lactating woman

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group 1
Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F1(1 tab, once)/ Period 3: CKD-386 F2(1 tab, once)
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F1
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F2
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Experimenteel: Group 2
Period 1: D012, D326, D337(3 tabs, once) / Period 2: CKD-386 F2(1 tab, once)/ Period 3: CKD-386 F1(1 tab, once)
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F1
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F2
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Experimenteel: Group 3
Period 1: CKD-386 F1(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once) Period 3: CKD-386 F2(1 tab, once)
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F1
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F2
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Experimenteel: Group 4
Period 1: CKD-386 F1(1 tab, once) / Period 2: CKD-386 F2(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F1
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F2
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Experimenteel: Group 5
Period 1: CKD-386 F2(1 tab, once) / Period 2: D012, D326, D337(3 tabs, once)/ Period 3: CKD-386 F1(1 tab, once)
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F1
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F2
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
Experimenteel: Group 6
Period 1: CKD-386 F2(1 tab, once) / Period 2: CKD-386 F1(1 tab, once) / Period 3: D012, D326, D337(3 tabs, once)
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F1
A single oral dose of 1 tablet under fasting conditions for each period
Andere namen:
  • CKD-386 F2
A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Tijdsspanne: 0(predose)~72 hours
AUCt: Area under the concentration-time curve
0(predose)~72 hours
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Tijdsspanne: 0(predose)~72 hours
Cmax: Maximum plasma concentration of the drug
0(predose)~72 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Tijdsspanne: 0(predose)~72 hours
AUCinf: Area under the concentration-time curve from zero up to ∞
0(predose)~72 hours
tmax each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Tijdsspanne: 0(predose)~72 hours
tmax: Time to maximum plasma concentration
0(predose)~72 hours
AUCt/AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Tijdsspanne: 0(predose)~72 hours
AUCt/AUCinf: AUCt/AUCinf Ratio
0(predose)~72 hours
t1/2 each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
Tijdsspanne: 0(predose)~72 hours
t1/2: Terminal elimination half-life
0(predose)~72 hours
AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
Tijdsspanne: 0(predose)~72 hours
AUCt: Area under the concentration-time curve
0(predose)~72 hours
Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
Tijdsspanne: 0(predose)~72 hours
Cmax: Maximum plasma concentration of the drug
0(predose)~72 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: 70-4665-9174 70-4665-9174, H Plus Yangji Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 februari 2020

Primaire voltooiing (Verwacht)

4 maart 2020

Studie voltooiing (Verwacht)

15 juni 2020

Studieregistratiedata

Eerst ingediend

8 januari 2020

Eerst ingediend dat voldeed aan de QC-criteria

8 januari 2020

Eerst geplaatst (Werkelijk)

10 januari 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 januari 2020

Laatste update ingediend die voldeed aan QC-criteria

8 januari 2020

Laatst geverifieerd

1 januari 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • A83_04BE1917P

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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