ID

38641

Beskrivning

A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet; ODM derived from: https://clinicaltrials.gov/show/NCT01388153

Länk

https://clinicaltrials.gov/show/NCT01388153

Nyckelord

Versioner (1)
  1. 2019-10-29 2019-10-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01388153

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT01388153

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
the informed consent must be signed before any study specific tests or procedures are done
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
healthy male subject
Beskrivning

Gender Healthy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
age: 18 to 45 years (inclusive) at the first screening examination / visit
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ethnicity: white
Beskrivning

White people

Datatyp

boolean

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

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
confirmation of the subject's health insurance coverage prior to the first screening examination / visit
Beskrivning

Study Subject Health Insurance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0021682
ability to understand and follow study-related instructions
Beskrivning

Instructions Study Protocol Comprehension | Adherence Instructions Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1442085
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0162340
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C1442085
UMLS CUI [2,3]
C2348563
Exclusion Criteria
Beskrivning

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
Beskrivning

Disease Cured Incomplete | Absorption Investigational New Drugs Abnormal | Distribution Investigational New Drugs Abnormal | Metabolism Investigational New Drugs Abnormal | Elimination Investigational New Drugs Abnormal | Effects Investigational New Drugs Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1880198
UMLS CUI [1,3]
C0205257
UMLS CUI [2,1]
C0237442
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0205161
UMLS CUI [3,1]
C1378698
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C0205161
UMLS CUI [4,1]
C0025519
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C0205161
UMLS CUI [5,1]
C0221102
UMLS CUI [5,2]
C0013230
UMLS CUI [5,3]
C0205161
UMLS CUI [6,1]
C1280500
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
Beskrivning

Disease Study Subject Participation Status Impaired | Condition Study Subject Participation Status Impaired | Medical History Study Subject Participation Status Impaired | Disease Completion of clinical trial Impaired | Condition Completion of clinical trial Impaired | Medical History Completion of clinical trial Impaired

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0221099
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0221099
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0221099
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C2732579
UMLS CUI [4,3]
C0221099
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C2732579
UMLS CUI [5,3]
C0221099
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C2732579
UMLS CUI [6,3]
C0221099
known hypersensitivity to the study drugs (active substances or excipients of the preparations)
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient

Datatyp

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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C2945656
UMLS CUI [2,1]
C0041755
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C1527304
UMLS CUI [3]
C0743280
chronic intestinal disorders associated with distinct disturbances of digestion and absorption
Beskrivning

Intestinal Diseases chronic Associated with Abnormal digestive tract function | Intestinal Diseases chronic Associated with Malabsorption

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021831
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0232459
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)
Beskrivning

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

Datatyp

boolean

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

Fasting blood glucose abnormal

Datatyp

boolean

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

Impaired glucose tolerance Glucose tolerance test

Datatyp

boolean

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

Eligibility Diabetes Mellitus, Type 2 NCT01388153

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
the informed consent must be signed before any study specific tests or procedures are done
boolean
C0021430 (UMLS CUI [1])
Gender Healthy
Item
healthy male subject
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
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])
Study Subject Health Insurance
Item
confirmation of the subject's health insurance coverage prior to the first screening examination / visit
boolean
C0681850 (UMLS CUI [1,1])
C0021682 (UMLS CUI [1,2])
Instructions Study Protocol Comprehension | Adherence Instructions Study Protocol
Item
ability to understand and follow study-related instructions
boolean
C1442085 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C1510802 (UMLS CUI [2,1])
C1442085 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Disease Cured Incomplete | Absorption Investigational New Drugs Abnormal | Distribution Investigational New Drugs Abnormal | Metabolism Investigational New Drugs Abnormal | Elimination Investigational New Drugs Abnormal | Effects 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])
C1880198 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C0237442 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C1378698 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0205161 (UMLS CUI [3,3])
C0025519 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C0205161 (UMLS CUI [4,3])
C0221102 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C0205161 (UMLS CUI [5,3])
C1280500 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C0205161 (UMLS CUI [6,3])
Disease Study Subject Participation Status Impaired | Condition Study Subject Participation Status Impaired | Medical History Study Subject Participation Status Impaired | Disease Completion of clinical trial Impaired | Condition Completion of clinical trial Impaired | Medical History Completion of clinical trial Impaired
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])
C2348568 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C2732579 (UMLS CUI [4,2])
C0221099 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C2732579 (UMLS CUI [5,2])
C0221099 (UMLS CUI [5,3])
C0262926 (UMLS CUI [6,1])
C2732579 (UMLS CUI [6,2])
C0221099 (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 Except 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 [2,1])
C0332300 (UMLS CUI [2,2])
C1527304 (UMLS CUI [2,3])
C0743280 (UMLS CUI [3])
Intestinal Diseases chronic Associated with Abnormal digestive tract function | 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])
C0232459 (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 | 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])
C0877059 (UMLS CUI [2])
C0019270 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0021843 (UMLS CUI [4])
C0151971 (UMLS CUI [5])
C0010346 (UMLS CUI [6])
C0009324 (UMLS CUI [7])
C3714745 (UMLS CUI [8])
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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