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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

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.

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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

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

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