ID

38751

Descrição

A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg; ODM derived from: https://clinicaltrials.gov/show/NCT01554631

Link

https://clinicaltrials.gov/show/NCT01554631

Palavras-chave

Versões (1)
  1. 31/10/2019 31/10/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

31 de outubro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01554631

Inglês

Eligibility Diabetes Mellitus, Type 2 NCT01554631

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male subject
Descrição

Healthy Volunteers | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0079399
age: 18 to 45 years (inclusive) at the first screening examination / visit
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ethnicity: white
Descrição

White people

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043157
body mass index (bmi): above/equal 18 and below/equal 28 kg / m²
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
Descrição

Disease Pre-existing Cured Incomplete | Investigational New Drugs Absorption Abnormal | Investigational New Drugs Distribution Abnormal | Investigational New Drugs Metabolism Abnormal | Investigational New Drugs Elimination Abnormal | Effects of Investigational New Drugs Abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1880198
UMLS CUI [1,4]
C0205257
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0237442
UMLS CUI [2,3]
C0205161
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1378698
UMLS CUI [3,3]
C0205161
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0025519
UMLS CUI [4,3]
C0205161
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C0221102
UMLS CUI [5,3]
C0205161
UMLS CUI [6,1]
C1704420
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C0205161
subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
Descrição

Disease Impairing Study Subject Participation Status | Medical condition Impairing Study Subject Participation Status | Medical History Impairing Study Subject Participation Status | Disease Impairing Completion of clinical trial | Medical condition Impairing Completion of clinical trial | Medical History Impairing Completion of clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C2732579
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0221099
UMLS CUI [5,3]
C2732579
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C0221099
UMLS CUI [6,3]
C2732579
known hypersensitivity to the study drugs (active substances or excipients of the preparations)
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
known severe allergies, non-allergic drug reactions, or multiple drug allergies
Descrição

Severe allergy | Adverse reaction to drug | Exception Allergic Reaction | DRUG ALLERGY MULTIPLE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2945656
UMLS CUI [2]
C0041755
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1527304
UMLS CUI [4]
C0743280
chronic intestinal disorders associated with distinct disturbances of digestion and absorption
Descrição

Intestinal Diseases chronic Associated with Digestive Disorders | Intestinal Diseases chronic Associated with Malabsorption

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021831
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0012242
UMLS CUI [2,1]
C0021831
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C3714745
states which may deteriorate as a result of increased gas formation in the intestine (e.g. roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, crohn´s disease, ulcerative colitis, malabsorptions)
Descrição

GAS FORMATION Increased Intestine | With result Deterioration of status | Roemheld syndrome | Hernia Major | Intestinal Obstruction | Primary ulcer of intestine | Crohn Disease | Ulcerative Colitis | Malabsorption

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0744271
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0021853
UMLS CUI [2,1]
C0332294
UMLS CUI [2,2]
C1279889
UMLS CUI [3]
C0877059
UMLS CUI [4,1]
C0019270
UMLS CUI [4,2]
C0205164
UMLS CUI [5]
C0021843
UMLS CUI [6]
C0151971
UMLS CUI [7]
C0010346
UMLS CUI [8]
C0009324
UMLS CUI [9]
C3714745
fasting blood glucose level outside normal range
Descrição

Fasting blood glucose abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948681
impaired glucose tolerance in glucose tolerance test
Descrição

Impaired glucose tolerance Glucose tolerance test

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0271650
UMLS CUI [1,2]
C0017741
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01554631

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Gender
Item
healthy male subject
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Age
Item
age: 18 to 45 years (inclusive) at the first screening examination / visit
boolean
C0001779 (UMLS CUI [1])
White people
Item
ethnicity: white
boolean
C0043157 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): above/equal 18 and below/equal 28 kg / m²
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Pre-existing Cured Incomplete | Investigational New Drugs Absorption Abnormal | Investigational New Drugs Distribution Abnormal | Investigational New Drugs Metabolism Abnormal | Investigational New Drugs Elimination Abnormal | Effects of Investigational New Drugs Abnormal
Item
incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
boolean
C0012634 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1880198 (UMLS CUI [1,3])
C0205257 (UMLS CUI [1,4])
C0013230 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C1378698 (UMLS CUI [3,2])
C0205161 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4,1])
C0025519 (UMLS CUI [4,2])
C0205161 (UMLS CUI [4,3])
C0013230 (UMLS CUI [5,1])
C0221102 (UMLS CUI [5,2])
C0205161 (UMLS CUI [5,3])
C1704420 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C0205161 (UMLS CUI [6,3])
Disease Impairing Study Subject Participation Status | Medical condition Impairing Study Subject Participation Status | Medical History Impairing Study Subject Participation Status | Disease Impairing Completion of clinical trial | Medical condition Impairing Completion of clinical trial | Medical History Impairing Completion of clinical trial
Item
subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
boolean
C0012634 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
C0262926 (UMLS CUI [6,1])
C0221099 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient
Item
known hypersensitivity to the study drugs (active substances or excipients of the preparations)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Severe allergy | Adverse reaction to drug | Exception Allergic Reaction | DRUG ALLERGY MULTIPLE
Item
known severe allergies, non-allergic drug reactions, or multiple drug allergies
boolean
C2945656 (UMLS CUI [1])
C0041755 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1527304 (UMLS CUI [3,2])
C0743280 (UMLS CUI [4])
Intestinal Diseases chronic Associated with Digestive Disorders | Intestinal Diseases chronic Associated with Malabsorption
Item
chronic intestinal disorders associated with distinct disturbances of digestion and absorption
boolean
C0021831 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0012242 (UMLS CUI [1,4])
C0021831 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C3714745 (UMLS CUI [2,4])
GAS FORMATION Increased Intestine | With result Deterioration of status | Roemheld syndrome | Hernia Major | Intestinal Obstruction | Primary ulcer of intestine | Crohn Disease | Ulcerative Colitis | Malabsorption
Item
states which may deteriorate as a result of increased gas formation in the intestine (e.g. roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, crohn´s disease, ulcerative colitis, malabsorptions)
boolean
C0744271 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0021853 (UMLS CUI [1,3])
C0332294 (UMLS CUI [2,1])
C1279889 (UMLS CUI [2,2])
C0877059 (UMLS CUI [3])
C0019270 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0021843 (UMLS CUI [5])
C0151971 (UMLS CUI [6])
C0010346 (UMLS CUI [7])
C0009324 (UMLS CUI [8])
C3714745 (UMLS CUI [9])
Fasting blood glucose abnormal
Item
fasting blood glucose level outside normal range
boolean
C0948681 (UMLS CUI [1])
Impaired glucose tolerance Glucose tolerance test
Item
impaired glucose tolerance in glucose tolerance test
boolean
C0271650 (UMLS CUI [1,1])
C0017741 (UMLS CUI [1,2])
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