A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 150 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications are provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets containing the individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets).
The tablets will be of the same strength (150 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components administered concurrently; Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of the 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Arizona
-
Tempe, Arizona, États-Unis
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Must sign an informed consent document indicating they understand the purpose of the study and procedures
- Must have a body mass index (BMI) of between 18 and 30 kg/m2, inclusive
- Must have a body weight of not less than 50 kg - Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)
Exclusion Criteria:
- History of or current clinically significant medical illness
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
- History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
- Known allergy to heparin or history of heparin induced thrombocytopenia
- Donated blood or blood products or had substantial loss of blood within 3 months before screening
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Treatment A
Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 300 mg, and 4 tablets of metformin extended release (MET XR), 500 mg each, administered together under fed conditions.
|
Chaque comprimé contient de la canagliflozine (CANA) de 300 mg à prendre par voie orale (par la bouche).
Autres noms:
Chaque comprimé contient de la metformine à libération prolongée (MET XR), 500 mg, à prendre par voie orale (par la bouche).
Autres noms:
|
|
Expérimental: Traitement B
Chaque participant recevra une dose unique de 2 comprimés de CANA/MET XR FDC, formulation 1, dans des conditions nourries.
|
Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.
|
|
Expérimental: Traitement C
Chaque participant recevra une dose unique de 2 comprimés de CANA/MET XR FDC, formulation 2, dans des conditions nourries.
|
Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Plasma concentration of canagliflozin following administration of a single dose of study drug
Délai: Predose, (before tablet intake) up to 72 hours after dose
|
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
|
Predose, (before tablet intake) up to 72 hours after dose
|
|
Plasma concentration of metformin following administration of a single dose of study drug
Délai: Predose, up to 36 hours after dose
|
Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.
|
Predose, up to 36 hours after dose
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Percentage of participants with adverse events as a measure of safety and tolerability
Délai: Screening, up to Day 10 of the follow-up period
|
Screening, up to Day 10 of the follow-up period
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR103256
- 28431754DIA1044 (Autre identifiant: Janssen Research & Development, LLC)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .