Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations
2014. július 28. frissítette: UCB Pharma SA
Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch (2 mg/24 h) Comparing 2 Different Formulations
The primary objective of the study is to establish Bioequivalence (BE) of 2 different formulations of the 2 mg/24 hr (10 cm^2) Rotigotine transdermal patches in Chinese subjects.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
Bioequivalence will be concluded if the 90 % Confidence Intervals (CIs) for the ratio Treatment A/Treatment B are fully included in the acceptance range from 0.8-1.25 for AUC(0-t) and AUC, and within the acceptance range from 0.7 to 1.43 for Cmax.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
50
Fázis
- 1. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
-
Hong Kong, Kína
- 1
-
-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Férfi
Leírás
Inclusion Criteria:
- An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
- Subject is considered reliable and capable of adhering to the protocol, visit schedule, and patch application according to the judgment of the investigator
- Subject is willing and able to comply with all study requirements
- Subject is Chinese (with all 4 grandparents being of Chinese origin, as well), male, and aged between 18 and 40 years (inclusive)
- Subject is healthy (no clinically significant findings in any of the investigations at the Eligibility Assessment (EA))
- Subject has a body mass index between 19 kg/m² and 24 kg/m² (inclusive), and a body weight greater than or equal to 50 kg
- Subject agreed to practice a medically accepted method of contraception (eg, condom, spermicide) unless sexually abstinent for the duration of the study and up to 3 months after the final patch application
Exclusion Criteria:
- Subject has previously participated in this study or subject has previously been assigned to treatment in a Rotigotine study
- Subject has participated in another study of an Investigational Medicinal Product (IMP) (or a medical device) within the previous 3 months or is currently participating in another study of an IMP (or a medical device)
- Subject has a history of diagnosis, counseling, or treatment for chronic alcohol or drug abuse within the previous 2 years
- Subject has a known clinically significant allergy or known or suspected clinically significant drug hypersensitivity to any components of the IMP or comparable drugs that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subject has lifetime history of suicide attempt
- Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or has recently unresolved contact dermatitis
- Subject has an medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subject has a history or present condition of epilepsy and/or seizures
- Subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Treatment A - B
Single application of the test transdermal patch (Treatment A, Rotigotine PR2.2.1) for 24 hours, followed by a Wash-Out Period of 7 days and a single application of the reference transdermal patch (Treatment B, Rotigotine PR2.1.1)
for 24 hours.
|
Treatment A: Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours. Treatment B: Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours. |
|
Aktív összehasonlító: Treatment B - A
Single application of the reference transdermal patch (Treatment B, Rotigotine PR2.1.1)
for 24 hours, followed by a Wash-Out Period of 7 days and a single application of the test transdermal patch (Treatment A, Rotigotine PR2.2.1) for 24 hours.
|
Treatment A: Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours. Treatment B: Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
|
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC(0-t))
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application.
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application.
|
|
Area under the plasma concentration-time curve from zero up to Infinity (AUC)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
The maximum plasma concentration of unconjugated Rotigotine (Cmax)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Másodlagos eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
|
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg) (AUC(0-t) norm (apparent dose))
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg) (AUC(0-t) norm (BW))
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUCnorm (apparent dose))
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUCnorm (BW))
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Maximum plasma concentration of unconjugated Rotigotine normalized by apparent dose (Cmax, norm (apparent dose))
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Maximum plasma concentration of unconjugated Rotigotine normalized by body weight (Cmax, norm (BW))
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Time to reach a maximum plasma concentration of unconjugated Rotigotine after patch application (tmax)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Mean residence time (MRT)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Rate constant of elimination (λz)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Terminal half-life (t1/2)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Relative bioavailability calculated based on Cmax (fCmax)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Relative bioavailability calculated based on AUC (fAUC)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
|
Apparent total body clearance (CL/f)
Időkeret: Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2014. február 1.
Elsődleges befejezés (Tényleges)
2014. július 1.
A tanulmány befejezése (Tényleges)
2014. július 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2014. február 20.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2014. február 20.
Első közzététel (Becslés)
2014. február 25.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2014. július 29.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2014. július 28.
Utolsó ellenőrzés
2014. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- PD0011
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Egészséges
-
ArdelyxBefejezveHealthy Volunteers Food Interaction StudyEgyesült Államok
-
AstraZenecaBefejezveHealthy Volunteers Bioekvivalencia vagy Biohasznosulási tanulmányEgyesült Királyság
Klinikai vizsgálatok a Rotigotine PR2.2.1
-
UCB PharmaBefejezve
-
UCB Biopharma SRLMegszűntNyugtalan láb szindrómaEgyesült Államok
-
UCB BIOSCIENCES GmbHBefejezve
-
UCB BIOSCIENCES GmbHPharmaceutical Health Sciences; Bracket GlobalBefejezve
-
Otsuka Pharmaceutical Co., Ltd.BefejezveIdiopátiás nyugtalan láb szindróma
-
Otsuka Pharmaceutical Co., Ltd.Befejezve
-
UCB PharmaBefejezveParkinson kórNémetország, Ausztria, Egyesült Királyság
-
UCB Biopharma SRLMegszűntNyugtalan láb szindrómaEgyesült Államok
-
Luye Pharma Group Ltd.BefejezveParkinson kórEgyesült Államok
-
Serina TherapeuticsAktív, nem toborzó