ID

38840

Description

Bioequivalence Study for Acarbose / Metformin FDC; ODM derived from: https://clinicaltrials.gov/show/NCT01728740

Link

https://clinicaltrials.gov/show/NCT01728740

Keywords

Versions (1)
  1. 11/8/19 11/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type II NCT01728740

English

Eligibility Diabetes Mellitus, Type II NCT01728740

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (bmi): 18 to 28 kg/m2 (inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
results of glycosylated hemoglobin a1c (hba1c) value are within the normal range (4.3-5.6%, inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
results of the 75 g oral glucose tolerance test (ogtt) during screening show:
Description

Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0029161
blood glucose before ogtt <110 mg/dl.
Description

Blood glucose measurement | Status pre- Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0029161
blood glucose 1 hour after glucose loading <180 mg/dl
Description

Blood glucose measurement | Time since loading dose

Data type

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2]
C0429929
blood glucose 2 hours after glucose loading <140 mg/dl
Description

Blood glucose measurement | Time since loading dose

Data type

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2]
C0429929
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of relevant diseases of internal organs (diabetes mellitus, ileus, ileus-like symptoms, diseases that may significantly jeopardize body systems
Description

Disease Organ Internal | Diabetes Mellitus | Ileus | Symptoms Ileus Similar | Disease At risk Body system

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205102
UMLS CUI [2]
C0011849
UMLS CUI [3]
C1258215
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C1258215
UMLS CUI [4,3]
C2348205
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0460002
febrile illness within 1 week before drug administration
Description

Febrile illness

Data type

boolean

Alias
UMLS CUI [1]
C0743841
family history of diabetes (within the second degree of relationship)
Description

Family history of diabetes mellitus Second Degree Relative

Data type

boolean

Alias
UMLS CUI [1,1]
C1313937
UMLS CUI [1,2]
C1519210
known drug hypersensitivity or idiosyncrasy
Description

Drug Allergy | Adverse reaction to drug

Data type

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0041755
known severe allergies, non-allergic drug reactions, or multiple drug allergies
Description

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

Data type

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
habitual medication including chinese herbal drugs
Description

Pharmaceutical Preparations Habitual | Drugs, Chinese Herbal

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205353
UMLS CUI [2]
C0013229
intake of any drugs within 2 weeks of drug administration of period 1
Description

Pharmaceutical Preparations | Clinical Trial Period Number

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2,1]
C2347804
UMLS CUI [2,2]
C0237753
regular daily consumption of more than 1 l of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
Description

Alcohol consumption Beer U/day | Alcohol consumption Equivalent U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0004922
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C0456683
donation of more than 150 ml of blood within 4 weeks before the screening examination
Description

Blood Donation Amount Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
participation in another clinical trial within 4 weeks before the screening examination
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Diabetes Mellitus, Type II NCT01728740

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
body mass index (bmi): 18 to 28 kg/m2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
results of glycosylated hemoglobin a1c (hba1c) value are within the normal range (4.3-5.6%, inclusive)
boolean
C0474680 (UMLS CUI [1])
Oral Glucose Tolerance Test
Item
results of the 75 g oral glucose tolerance test (ogtt) during screening show:
boolean
C0029161 (UMLS CUI [1])
Blood glucose measurement | Status pre- Oral Glucose Tolerance Test
Item
blood glucose before ogtt <110 mg/dl.
boolean
C0392201 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0029161 (UMLS CUI [2,2])
Blood glucose measurement | Time since loading dose
Item
blood glucose 1 hour after glucose loading <180 mg/dl
boolean
C0392201 (UMLS CUI [1])
C0429929 (UMLS CUI [2])
Blood glucose measurement | Time since loading dose
Item
blood glucose 2 hours after glucose loading <140 mg/dl
boolean
C0392201 (UMLS CUI [1])
C0429929 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Disease Organ Internal | Diabetes Mellitus | Ileus | Symptoms Ileus Similar | Disease At risk Body system
Item
a history of relevant diseases of internal organs (diabetes mellitus, ileus, ileus-like symptoms, diseases that may significantly jeopardize body systems
boolean
C0012634 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205102 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2])
C1258215 (UMLS CUI [3])
C1457887 (UMLS CUI [4,1])
C1258215 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0460002 (UMLS CUI [5,3])
Febrile illness
Item
febrile illness within 1 week before drug administration
boolean
C0743841 (UMLS CUI [1])
Family history of diabetes mellitus Second Degree Relative
Item
family history of diabetes (within the second degree of relationship)
boolean
C1313937 (UMLS CUI [1,1])
C1519210 (UMLS CUI [1,2])
Drug Allergy | Adverse reaction to drug
Item
known drug hypersensitivity or idiosyncrasy
boolean
C0013182 (UMLS CUI [1])
C0041755 (UMLS CUI [2])
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])
Pharmaceutical Preparations Habitual | Drugs, Chinese Herbal
Item
habitual medication including chinese herbal drugs
boolean
C0013227 (UMLS CUI [1,1])
C0205353 (UMLS CUI [1,2])
C0013229 (UMLS CUI [2])
Pharmaceutical Preparations | Clinical Trial Period Number
Item
intake of any drugs within 2 weeks of drug administration of period 1
boolean
C0013227 (UMLS CUI [1])
C2347804 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Alcohol consumption Beer U/day | Alcohol consumption Equivalent U/day
Item
regular daily consumption of more than 1 l of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
boolean
C0001948 (UMLS CUI [1,1])
C0004922 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0001948 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Blood Donation Amount Timespan
Item
donation of more than 150 ml of blood within 4 weeks before the screening examination
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Study Subject Participation Status
Item
participation in another clinical trial within 4 weeks before the screening examination
boolean
C2348568 (UMLS CUI [1])
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