ID

37328

Description

Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State; ODM derived from: https://clinicaltrials.gov/show/NCT02223065

Link

https://clinicaltrials.gov/show/NCT02223065

Keywords

Versions (1)
  1. 7/17/19 7/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02223065

English

Eligibility Type 2 Diabetes Mellitus NCT02223065

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's irb or iec before the initiation of any protocol-required procedures.
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
2. target population
Description

Target Population

Data type

boolean

Alias
UMLS CUI [1]
C0039309
healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ecg measurements, physical measurements, and clinical laboratory test results.
Description

Healthy Volunteers | Medical History Normal | Psychiatric History Normal | Physical examination normal | Normal vital signs | 12 lead ECG Normal | Physical measurements Normal | Normal Laboratory Test Result

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C0748059
UMLS CUI [3,2]
C0205307
UMLS CUI [4]
C0855737
UMLS CUI [5]
C0277803
UMLS CUI [6,1]
C0430456
UMLS CUI [6,2]
C0205307
UMLS CUI [7,1]
C0695448
UMLS CUI [7,2]
C0205307
UMLS CUI [8]
C0438214
3. age and reproductive status
Description

Age | Reproduction Status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0035150
UMLS CUI [2,2]
C0449438
males and females, ages 19 to 55 years, inclusive. to extent possible, the distribution of men and women between the sequences will be balanced
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug.
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | hCG measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3]
C0428402
women must not be breastfeeding.
Description

Gender | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any significant acute or chronic medical illness.
Description

Illness | Chronic disease

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0008679
current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
Description

Gastrointestinal Disease Impact Absorption Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
any major surgery within 4 weeks of study drug administration.
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
use of tobacco- or nicotine- containing products within 6 months before check-in
Description

Tobacco use | Use of Nicotine product

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0028040
any other sound medical, psychiatric, and/or social reason as determined by the investigator.
Description

Cause Medical | Cause Psychiatric | Cause social

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205476
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0205487
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0728831
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02223065

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's irb or iec before the initiation of any protocol-required procedures.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Target Population
Item
2. target population
boolean
C0039309 (UMLS CUI [1])
Healthy Volunteers | Medical History Normal | Psychiatric History Normal | Physical examination normal | Normal vital signs | 12 lead ECG Normal | Physical measurements Normal | Normal Laboratory Test Result
Item
healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ecg measurements, physical measurements, and clinical laboratory test results.
boolean
C1708335 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0748059 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0855737 (UMLS CUI [4])
C0277803 (UMLS CUI [5])
C0430456 (UMLS CUI [6,1])
C0205307 (UMLS CUI [6,2])
C0695448 (UMLS CUI [7,1])
C0205307 (UMLS CUI [7,2])
C0438214 (UMLS CUI [8])
Age | Reproduction Status
Item
3. age and reproductive status
boolean
C0001779 (UMLS CUI [1])
C0035150 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
Age
Item
males and females, ages 19 to 55 years, inclusive. to extent possible, the distribution of men and women between the sequences will be balanced
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | hCG measurement
Item
women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0428402 (UMLS CUI [3])
Gender | Breast Feeding Absent
Item
women must not be breastfeeding.
boolean
C0079399 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Illness | Chronic disease
Item
any significant acute or chronic medical illness.
boolean
C0221423 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Gastrointestinal Disease Impact Absorption Investigational New Drug
Item
current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
boolean
C0017178 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Major surgery
Item
any major surgery within 4 weeks of study drug administration.
boolean
C0679637 (UMLS CUI [1])
Tobacco use | Use of Nicotine product
Item
use of tobacco- or nicotine- containing products within 6 months before check-in
boolean
C0543414 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
Cause Medical | Cause Psychiatric | Cause social
Item
any other sound medical, psychiatric, and/or social reason as determined by the investigator.
boolean
C0015127 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0728831 (UMLS CUI [3,2])
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