- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01332071
Avandamet Bioequivalence Study Brazil - Fed Administration
14 juin 2017 mis à jour par: GlaxoSmithKline
Assessment of Relative Bioavailability of Avandamet 4 mg + 1000 mg (GSK) in the Form of Film Coated Tablets Versus Avandamet 2 mg + 500 mg (GSK) in the Form of Film Coated Tablets, in Healthy Volunteers After Feeding Standardized, Using Liquid Chromatography.
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods.
The volunteers received, in each period, the reference or the test formulation after standardized meals.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals.
Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets.
Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith Kline Brasil Ltda) in the form of film coated tablets.
The population is composed by 26 healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years.
Their body mass index (BMI) varied between 18,5 and 25.
There are no restrictions regarding the ethnic group.
The relative bioavailability of the two formulations, after oral administration, will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood.
Type d'étude
Interventionnel
Inscription (Réel)
26
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Goiás
-
Goiania, Goiás, Brésil
- GSK Investigational Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 50 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
EXCLUSION CRITERIA:
- The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;
- History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
- Hypo or hypertension of any etiologic that needs pharmacologic treatment;
- The results of the laboratory exams are out of the values considered as normal according this protocol's rules, unless that they are considered as clinically irrelevant by the investigator;
- Has history of alcohol or drugs abuse;
- History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
- Use of MAO inhibitors two weeks before the start of treatment; - Use of inhibitors of 5-TH reuptake,
- Pregnancy or breastfeeding,
- Smoking;
- Use of regular medication within 4 weeks prior to study iniciation;
- Use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.
INCLUSION CRITERIA:
- Age between 18 and 50 years;
- Body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
- Good health conditions;
- Obtain the Informed Consent's signed.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Avandamet test product
Test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 miligrams (mg) + 1000 mg in Period 1, followed by a 7-day washout period during which no medication was administered, followed by reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 mg + 500 mg in Period 2
|
Avandamet test product
|
|
Comparateur actif: Avandamet reference product
Reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 miligrams (mg) + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 mg + 1000 mg in Period 2
|
Avandamet reference product
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
AUC0-t of Rosiglitazone Maleate
Délai: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanograms; ml, milliliter.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
Cmax of Rosiglitazone Maleate
Délai: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration.
Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
AUC0-infinity of Rosiglitazone Maleate
Délai: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
AUC0-t of Metformin Hydrochloride
Délai: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanograms; ml, milliliter.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
AUC0-infinity of Metformin Hydrochloride
Délai: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug).
The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
|
Cmax of Metformin Hydrochloride
Délai: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration.
Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
|
Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
24 novembre 2009
Achèvement primaire (Réel)
6 décembre 2009
Achèvement de l'étude (Réel)
6 décembre 2009
Dates d'inscription aux études
Première soumission
31 août 2010
Première soumission répondant aux critères de contrôle qualité
17 mars 2011
Première publication (Estimation)
8 avril 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juillet 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 juin 2017
Dernière vérification
1 juin 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 114040
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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 .