- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07655960
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults
16. juni 2026 opdateret af: AJU Pharm Co., Ltd.
An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over to Evaluate the Safety and Pharmacokinetics of AJU-C716 Compared to C716R in Healthy Adult Volunteers
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Seoul, Sydkorea
- H+ Yangji Hospital, Seoul, Republic of South Korea
-
-
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
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Healthy adults between 19 and 55 years of age at the time of screening.
- Weight ≥ 50 kg for men or ≥ 45 kg for women, with a calculated body mass index(BMI) of 18 to 30 kg/m² at the time of screening.
- Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.
- Those who are eligible for the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening.
- Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial.
- Those who agree to use highly effective methods of contraception(excluding hormonal methods) to prevent pregnancy, either for themselves or their spouse/partner, from the first administration of the investigational medicinal product until one week after the last administration, and who agree not to donate sperm or eggs during this period.
Exclusion Criteria:
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days.
- Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
- Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study.
- Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
- Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.
Those who has under
- Those who are hypersensitive to component of the Investigational product and have the medical history
- Those with active liver disease or persistent elevation of aminotransferase levels of unknown
- Individuals with severe hepatic impairment, biliary obstruction, or cholestasis
- Those taking cyclosporin
- Those with myopathy
- Those with a history of hypersensitivity or allergy to Sunset Yellow FCF (Yellow No. 5, Sunset Yellow FCF).
- Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- Those who has a history of mental illness.
- Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons.
- Women who are pregnant or who may be pregnant and breastfeed.
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: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sequence A
Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose
|
AJU-C716
C716R
|
|
Eksperimentel: Sequence B
Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose
|
AJU-C716
C716R
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
AUCt of AJU-C716
Tidsramme: Pre-dose(0 hours) ~ 36 hours
|
Pre-dose(0 hours) ~ 36 hours
|
|
Cmax of AJU-C716
Tidsramme: Pre-dose(0 hours) ~ 36 hours
|
Pre-dose(0 hours) ~ 36 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ka of AJU-C716
Tidsramme: Pre-dose(0 hours) ~ 36 hours
|
Pre-dose(0 hours) ~ 36 hours
|
|
Percentage of concentration relative to Cmax of AJU-C716
Tidsramme: Pre-dose(0 hours) ~ 36 hours
|
Pre-dose(0 hours) ~ 36 hours
|
|
AUCinf of AJU-C716
Tidsramme: Pre-dose(0 hours) ~ 36 hours
|
Pre-dose(0 hours) ~ 36 hours
|
|
AUCt/AUCinf of AJU-C716
Tidsramme: Pre-dose(0 hours) ~ 36 hours
|
Pre-dose(0 hours) ~ 36 hours
|
|
t1/2 of AJU-C716
Tidsramme: Pre-dose(0 hours) ~ 36 hours
|
Pre-dose(0 hours) ~ 36 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
11. juni 2026
Primær færdiggørelse (Anslået)
26. juni 2026
Studieafslutning (Anslået)
26. juni 2026
Datoer for studieregistrering
Først indsendt
9. april 2026
Først indsendt, der opfyldte QC-kriterier
16. juni 2026
Først opslået (Faktiske)
18. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26PHL12001
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 .
Kliniske forsøg med Test Drug
-
Case Comprehensive Cancer CenterFlorida International University; Community Foundation of BrowardAktiv, ikke rekrutterendeTilbagefaldende kræft | Ildfast kræftForenede Stater
-
Suzhou Centergene Pharmaceuticals Co.,Ltd.RekrutteringAssisteret reproduktionsteknologi | Kvindelig InfertilitetKina
-
AmgenIkke rekrutterer endnu
-
Oncosyne ASUniversity Hospital, Akershus; CTC Clinical Trial Consultants ABRekrutteringMetastatisk kolorektal cancer (mCRC)Norge
-
University Hospital, Strasbourg, FranceAktiv, ikke rekrutterende
-
Dong-A Pharmaceutical Co., Ltd.AfsluttetEn undersøgelse til evaluering af tolerabilitet, sikkerhed og farmakokinetiske egenskaber af DA-3803Infertilitet | Fremkaldelse af ægløsning
-
Shanghai 10th People's HospitalIkke rekrutterer endnu
-
University of MiamiAfsluttet
-
AmgenRekrutteringFarmakokinetik | Sunde deltagereForenede Stater
-
Medical University of South CarolinaWayne State University; National Institute on Minority Health and Health... og andre samarbejdspartnereAfsluttet