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Avandamet Bioequivalence Study Brazil - Fed Administration

2017年6月14日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

26

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Goiás
      • Goiania、Goiás、ブラジル
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~50年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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
アクティブコンパレータ: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
AUC0-t of Rosiglitazone Maleate
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2009年11月24日

一次修了 (実際)

2009年12月6日

研究の完了 (実際)

2009年12月6日

試験登録日

最初に提出

2010年8月31日

QC基準を満たした最初の提出物

2011年3月17日

最初の投稿 (見積もり)

2011年4月8日

学習記録の更新

投稿された最後の更新 (実際)

2017年7月12日

QC基準を満たした最後の更新が送信されました

2017年6月14日

最終確認日

2017年6月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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