Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
An Open-lable, Randomized, Fasting, Single-dose, Oral Administration, 2-sequence, 4-period, Replicate Crossover Study to Evaluate Bioequivalence Between YHP2508A and YHR2601 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508A and YHR2601 in healthy subjects
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
44 healthy subjects wiil be randomized to one of 2 groups in the same ration.
Subjects in group 1 will be administered "YHR2601" and "YHP2508A" by crossover design on periods 1 to 4.
Subjects in group 2 will be administered "YHP2508A" and "YHR2601" by crossover design on periods 1 to 4.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Jungwook Lee, MS
- Telefonnummer: 82-2-828-0504
- E-mail: clinicaltrials@yuhan.co.kr
Studiesteder
-
-
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Seoul, Sydkorea
- Rekruttering
- H+ Yangji Hospital
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Kontakt:
- H+YANGJI HOSPITAL
- Telefonnummer: +82-70-4665-9490
- E-mail: juspa@newyjh.com
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Kontakt:
- H+YANGJI HOSPITAL
- Telefonnummer: +82-70-4665-9519
- E-mail: hplus.us@gmail.com
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Ledende efterforsker:
- SEUNG-HYUN KANG, MD
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- BMI 18-30 kg/m2
- Those without clinically significant congenital or chronic diseases
Exclusion Criteria:
- Those who have participated in a bioequivalence study or other clinical trials and have been administered investigational products within 6 months prior to the first administration
- Those who are judged ineligible to participate in the trial by the principal investigator
- Female volunteers who are pregnant, suspected to be pregnant or breathfeeding
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: A(RTRT)
22 subjects, Cross-over, Single dose YHR2601 on period 1 and 3, Single dose of YHP2508A on period 2 and 4. |
Test Drug Comparator drug |
|
Eksperimentel: B(TRTR)
22 subjects, Cross-over, Single dose YHP2508A on period 1 and 3, Single dose of YHR2601 on period 2 and 4. |
Test Drug Comparator drug |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area under the plasma drug concentration-time curve [AUCt]
Tidsramme: 0-72 hours
|
Area under the plasma drug concentration-time curve [AUCt] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
|
Maximum plasma concentration [Cmax]
Tidsramme: 0-72 hours
|
Maximum plasma concentration [Cmax] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time of peak concentration [Tmax]
Tidsramme: 0-72 hours
|
Time of peak concentration [Tmax] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
|
Terminal phase of half-life [t1/2]
Tidsramme: 0-72 hours
|
Terminal phase of half-life [t1/2] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
|
Area under the plasma drug concentration-time curve from 0 to infinity [AUCinf]
Tidsramme: 0-72 hours
|
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Amlodipine, Telmisartan & Chlothalidone |
0-72 hours
|
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from 0 to infinity [AUCt/AUCinf]
Tidsramme: 0-72 hours
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Amlodipine, Telmisartan & Chlorthalidone |
0-72 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Nøgleord
Andre undersøgelses-id-numre
- YHP2508-103
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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