- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04694989
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2)
An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Gwanak-gu
-
Seoul, Gwanak-gu, Korea, Republikken, 08779
- H Plus Yangji Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
Those who meet the blood pressure criteria during screening tests:
- Systolic Blood Pressure: 90 to 139 mmHg
- Diastolic Blood Pressure: 60 to 89 mmHg
- Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
- Those who agree to contraception during the participation of clinical trial.
- Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria:
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
- Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
Those who exceed an alcohol and cigarette consumption than below criteria
• Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
• Smoking: 20 cigarettes/day
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
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who are deemed insufficient to participate in this clinical study by investigators.
- Woman who are pregnant or breastfeeding.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sequence 1
Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-386- A single oral dose of 1 tablet under fasting condition Period 3: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-386- A single oral dose of 1 tablet under fasting condition |
QD, PO
QD, PO
|
|
Eksperimentel: Sequence 2
Period 1: CKD-386- A single oral dose of 1 tablet under fasting condition Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-386- A single oral dose of 1 tablet under fasting condition Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition |
QD, PO
QD, PO
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AUCt af CKD-386
Tidsramme: Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
AUCt: Areal under koncentration-tid-kurven fra tid nul til tid
|
Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
|
Cmax på CKD-386
Tidsramme: Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
Maksimal plasmakoncentration af lægemidlet
|
Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AUCinf af CKD-386
Tidsramme: Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
AUCinf: Areal under koncentration-tid-kurven fra nul op til ∞
|
Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
|
Tmax på CKD-386
Tidsramme: Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
Tmax: Tid til maksimal plasmakoncentration
|
Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
|
AUCt/AUCinf af CKD-386
Tidsramme: Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
AUCt/AUCinf
|
Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
|
T1/2 af CKD-386
Tidsramme: Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
T1/2: Terminal halveringstid for eliminering
|
Præ-dosis (0 timer), 0,25, 0,5, 0,75, 1, 1,5, 2, 3, 4, 8, 12, 24, 48, 72 timer
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A83_05BE1918
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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