ID

32909

Description

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B); ODM derived from: https://clinicaltrials.gov/show/NCT00897390

Lien

https://clinicaltrials.gov/show/NCT00897390

Mots-clés

Versions (1)
  1. 19/11/2018 19/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Type 2 Diabetes Mellitus NCT00897390

Anglais

Eligibility Type 2 Diabetes Mellitus NCT00897390

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ages 19 to 45 inclusive
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations
Description

Healthy Volunteers | Medical History Normal | Physical examination normal | ECG normal | Laboratory test normal

Type de données

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205307
UMLS CUI [3]
C0855737
UMLS CUI [4]
C0522054
UMLS CUI [5]
C1096215
body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ [height (m)]2
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of child-bearing potential (wocbp) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
Description

Childbearing Potential Barrier Contraception Unwilling | Childbearing Potential Barrier Contraception Unable | Female Condoms | Vaginal Spermicides

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0004764
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0221829
UMLS CUI [4]
C0087145
any significant acute or chronic medical illness
Description

Illness | Chronic disease

Type de données

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0008679
current or recent (within 3 months) gastrointestinal disease
Description

Gastrointestinal Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0017178
any major surgery within 4 weeks of study drug administration
Description

Major surgery

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
history of allergy to dipeptidyl peptidase 4 (dpp4) inhibitor or related compounds
Description

Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Compound Related

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1827106
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0439849
history of allergy or intolerance to metformin or other similar acting agents
Description

Metformin allergy | Intolerance to Metformin | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar

Type de données

boolean

Alias
UMLS CUI [1]
C0571648
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C2348205
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
prior exposure to saxagliptin
Description

Exposure to Saxagliptin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1611934
prior exposure to metformin within 3 months of study drug administration
Description

Exposure to Metformin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0025598
estimated creatinine clearance (clcr) of < 80ml/min using the cockcroft gault formula
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C2711451
Retour au début de la page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00897390

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ages 19 to 45 inclusive
boolean
C0001779 (UMLS CUI [1])
Healthy Volunteers | Medical History Normal | Physical examination normal | ECG normal | Laboratory test normal
Item
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations
boolean
C1708335 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0855737 (UMLS CUI [3])
C0522054 (UMLS CUI [4])
C1096215 (UMLS CUI [5])
Body mass index
Item
body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ [height (m)]2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Barrier Contraception Unwilling | Childbearing Potential Barrier Contraception Unable | Female Condoms | Vaginal Spermicides
Item
women of child-bearing potential (wocbp) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0221829 (UMLS CUI [3])
C0087145 (UMLS CUI [4])
Illness | Chronic disease
Item
any significant acute or chronic medical illness
boolean
C0221423 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Gastrointestinal Disease
Item
current or recent (within 3 months) gastrointestinal disease
boolean
C0017178 (UMLS CUI [1])
Major surgery
Item
any major surgery within 4 weeks of study drug administration
boolean
C0679637 (UMLS CUI [1])
Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Compound Related
Item
history of allergy to dipeptidyl peptidase 4 (dpp4) inhibitor or related compounds
boolean
C0020517 (UMLS CUI [1,1])
C1827106 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Metformin allergy | Intolerance to Metformin | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar
Item
history of allergy or intolerance to metformin or other similar acting agents
boolean
C0571648 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Exposure to Saxagliptin
Item
prior exposure to saxagliptin
boolean
C0332157 (UMLS CUI [1,1])
C1611934 (UMLS CUI [1,2])
Exposure to Metformin
Item
prior exposure to metformin within 3 months of study drug administration
boolean
C0332157 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
estimated creatinine clearance (clcr) of < 80ml/min using the cockcroft gault formula
boolean
C2711451 (UMLS CUI [1])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial