ID

39375

Descrição

Avandamet Bioequivalence Study Brazil - Fed Administration; ODM derived from: https://clinicaltrials.gov/show/NCT01332071

Link

https://clinicaltrials.gov/show/NCT01332071

Palavras-chave

Versões (1)
  1. 04/01/2020 04/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Healthy Volunteers NCT01332071

Inglês

Eligibility Healthy Volunteers NCT01332071

1 Formulários  
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
Descrição

Healthy Volunteers | Hypersensitivity Investigational New Drugs | Hypersensitivity Compound Related

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C0439849
history or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;
Descrição

Liver diseases | Gastrointestinal Diseases | Condition Interferes with Drug absorption | Condition Interferes with Drug distribution | Condition Interferes with Drug elimination | Condition Interferes with Drug metabolism

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0017178
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0678745
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0699903
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0683141
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0683140
history of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
Descrição

Nervous system disorder | Endocrine System Diseases | Lung diseases | Hematological Disease | Immune System Diseases | Brain Diseases | Metabolic Diseases | Cardiovascular Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0021053
UMLS CUI [6]
C0006111
UMLS CUI [7]
C0025517
UMLS CUI [8]
C0007222
hypo or hypertension of any etiologic that needs pharmacologic treatment;
Descrição

Hypotension | Hypertensive disease | Requirement Pharmacotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0020538
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0013216
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;
Descrição

Laboratory test result abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438215
has history of alcohol or drugs abuse;
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
history of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
Descrição

Hepatic Metabolism inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1373178
UMLS CUI [1,2]
C0243077
use of mao inhibitors two weeks before the start of treatment; - use of inhibitors of 5-th reuptake,
Descrição

Monoamine Oxidase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026457
pregnancy or breastfeeding,
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
smoking;
Descrição

Tobacco use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543414
use of regular medication within 4 weeks prior to study iniciation;
Descrição

Medication use Regular

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0240320
UMLS CUI [1,2]
C0205272
use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.
Descrição

Investigational New Drugs | Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 18 and 50 years;
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
good health conditions;
Descrição

Good health

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3813622
obtain the informed consent's signed.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Healthy Volunteers NCT01332071

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C0680251 (UMLS CUI)
Healthy Volunteers | Hypersensitivity Investigational New Drugs | Hypersensitivity Compound Related
Item
the volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
boolean
C1708335 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Liver diseases | Gastrointestinal Diseases | Condition Interferes with Drug absorption | Condition Interferes with Drug distribution | Condition Interferes with Drug elimination | Condition Interferes with Drug metabolism
Item
history or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;
boolean
C0023895 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0678745 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0699903 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683141 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683140 (UMLS CUI [6,3])
Nervous system disorder | Endocrine System Diseases | Lung diseases | Hematological Disease | Immune System Diseases | Brain Diseases | Metabolic Diseases | Cardiovascular Diseases
Item
history of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
boolean
C0027765 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0006111 (UMLS CUI [6])
C0025517 (UMLS CUI [7])
C0007222 (UMLS CUI [8])
Hypotension | Hypertensive disease | Requirement Pharmacotherapy
Item
hypo or hypertension of any etiologic that needs pharmacologic treatment;
boolean
C0020649 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
Laboratory test result abnormal
Item
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;
boolean
C0438215 (UMLS CUI [1])
Substance Use Disorders
Item
has history of alcohol or drugs abuse;
boolean
C0038586 (UMLS CUI [1])
Hepatic Metabolism inhibitors
Item
history of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
boolean
C1373178 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
Monoamine Oxidase Inhibitors
Item
use of mao inhibitors two weeks before the start of treatment; - use of inhibitors of 5-th reuptake,
boolean
C0026457 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tobacco use
Item
smoking;
boolean
C0543414 (UMLS CUI [1])
Medication use Regular
Item
use of regular medication within 4 weeks prior to study iniciation;
boolean
C0240320 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Investigational New Drugs | Study Subject Participation Status
Item
use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 18 and 50 years;
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
boolean
C1305855 (UMLS CUI [1])
Good health
Item
good health conditions;
boolean
C3813622 (UMLS CUI [1])
Informed Consent
Item
obtain the informed consent's signed.
boolean
C0021430 (UMLS CUI [1])
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