Avandamet Bioequivalence Study Brazil - Fed Administration
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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Goiás
-
Goiania, Goiás, Brasilien
- GSK Investigational Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC0-t of Rosiglitazone Maleate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 114040
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