Healthy, non-smoking adult males and femals between 18 and 55 years
Item
Healthy, non-smoking (within 30 days of screening), adult males and females between 18 and 55 years of age, inclusive.
boolean
C3898900 (UMLS CUI [1])
C1519386 (UMLS CUI [2])
C0001675 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
Females of non-childbearing potential or of childbearing potential with negative pregnancy test and using certain contraceptive method(s)
Item
Female subjects are eligible for participation in the study if they are of: a Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b Childbearing potential, have a negative pregnancy test (urine or serum) at screening, one of the following applies: • Agree to complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for a time interval after completion of the study or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 3 days); or, • Female sterilization; or, • Sterilization of male partner; or, • Implants of levonorgestrel; or, • Injectable progestogen; or, • Oral contraceptive (combined or progestogen only); or • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1PERCENT per year (not all IUDs meet this criteria); or, • Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or, • Any other barrier methods (only if used in combination with any of the above acceptable methods); or, • Any other method with published data showing that the lowest expected failure rate is less than 1percent per year.
boolean
C0086287 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Stable regimen of oral contraceptives
Item
Any subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
boolean
C0009905 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
BMI: 20-32 kg/m2
Item
BMI: 20-32 kg/m2 , inclusive.
boolean
C1305855 (UMLS CUI [1])
QTc <450 msec or <480 msec if associated with bundle branch block
Item
Subject has a QTc <450 msec or <480 msec if associated with bundle branch block
boolean
C0489625 (UMLS CUI [1,1])
C0006384 (UMLS CUI [1,2])
Willing and able to provide written informed consent
Item
Subject is willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Migraine attacks
Item
Subjects who suffer from migraine attacks.
boolean
C0149931 (UMLS CUI [1])
Confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm
Item
Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal’s angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
boolean
C0002962 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0750484 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4,1])
C0750484 (UMLS CUI [4,2])
C0340291 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0340291 (UMLS CUI [6,1])
C0750484 (UMLS CUI [6,2])
C0002963 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0002963 (UMLS CUI [8,1])
C0750484 (UMLS CUI [8,2])
Ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome
Item
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s syndrome.
boolean
C0034734 (UMLS CUI [1])
C0085096 (UMLS CUI [2])
C0022116 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating the study participation
Item
Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram (ECG) abnormality that, in the investigator’s opinion, contraindicates participation in this study.
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1832603 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C1301624 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
History of cerebrovascular pathology including stroke and/or transient ischemic attacks
Item
Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
boolean
C0007820 (UMLS CUI [1])
C0559159 (UMLS CUI [2])
Congenital heart disease
Item
Subject has a history of congenital heart disease.
boolean
C0152021 (UMLS CUI [1])
Hypertension at screening
Item
Subject has hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Likely to have unrecognized cardiovascular or cerebrovascular disease (e.g. risk factors such as hypertension, hypercholesterolemia, prior smoking history, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age
Item
Subject, in the investigator’s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to hypertension, hypercholesterolemia, prior smoking history, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
boolean
C0007222 (UMLS CUI [1,1])
C4288068 (UMLS CUI [1,2])
C0007820 (UMLS CUI [2,1])
C4288068 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3])
C0020443 (UMLS CUI [4])
C1519384 (UMLS CUI [5])
C0028754 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0241889 (UMLS CUI [8,1])
C1956346 (UMLS CUI [8,2])
C0086287 (UMLS CUI [9,1])
C0025320 (UMLS CUI [9,2])
C0001779 (UMLS CUI [10,1])
C0086582 (UMLS CUI [10,2])
History of epilepsy or structural brain lesions lowering the convulsive threshold or recent treatment with an antiepileptic drug
Item
Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
boolean
C0455511 (UMLS CUI [1])
C0221505 (UMLS CUI [2,1])
C0234976 (UMLS CUI [2,2])
C0003299 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
History of impaired hepatic or renal function
Item
History of impaired hepatic or renal function.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Herbal preparations containing St. John's Wort (Hypericum perforatum) currently or recently taken
Item
Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John’s Wort (Hypericum perforatum).
boolean
C0521116 (UMLS CUI [1,1])
C1360419 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0936242 (UMLS CUI [1,4])
C0332185 (UMLS CUI [2,1])
C1360419 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0936242 (UMLS CUI [2,4])
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, excluded acetaminophen at certain doses and contraceptives
Item
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication. Note: Excluded from this list are: acetaminophen at doses of ≤ 2 grams/day and contraceptives.
boolean
C0013231 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C0332300 (UMLS CUI [6,1])
C0000970 (UMLS CUI [6,2])
C0332300 (UMLS CUI [7,1])
C0009871 (UMLS CUI [7,2])
History of hypersensitivity, intolerance or contraindication to the use of sumatriptan or naproxen sodium or any of their components or aspirin or any other 5-HT1 receptor agonist.
Item
Subject has a hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist.
boolean
C0020517 (UMLS CUI [1,1])
C0075632 (UMLS CUI [1,2])
C0277585 (UMLS CUI [2,1])
C0075632 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0075632 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0027396 (UMLS CUI [4,2])
C0277585 (UMLS CUI [5,1])
C0027396 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0027396 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0027396 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0004057 (UMLS CUI [8,2])
C0277585 (UMLS CUI [9,1])
C0004057 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0004057 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0162754 (UMLS CUI [11,2])
C0277585 (UMLS CUI [12,1])
C0162754 (UMLS CUI [12,2])
C1301624 (UMLS CUI [13,1])
C0162754 (UMLS CUI [13,2])
Gastrointestinal surgery due to bleeding, ulceration or perforation
Item
Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
boolean
C1963975 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0151664 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
History of gastric bypass or stapling surgery
Item
Subject has a history of gastric bypass or stapling surgery.
boolean
C0149701 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
History of GI ulceration or gastrointestinal bleeding
Item
Subject has a history of GI ulceration or gastrointestinal bleeding.
boolean
C1963975 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
History of inflammatory bowel disease
Item
Subject has a history of inflammatory bowel disease.
boolean
C0021390 (UMLS CUI [1])
Recent treatment with an investigational drug
Item
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Positive serum beta-hCG test (females)
Item
Positive beta-human chorionic gonadotropin (beta-hCG) test (females).
boolean
C1255526 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0086287 (UMLS CUI [1,3])
Pregnant, actively trying to become pregnant or breast-feeding
Item
Pregnant, actively trying to become pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
History of drug or alcohol abuse
Item
Subjects with a history of drug or alcohol abuse.
boolean
C0262926 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
Regular Alcohol consumption as measured by alcohol units/week
Item
History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,3])
Positive urine drug screening including alcohol
Item
Positive urine drug screen (UDS) including alcohol at screening.
boolean
C0743300 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C1112219 (UMLS CUI [1,3])
Infection status of hepatitis B, hepatitis C and HIV
Item
Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result or positive HIV result within 3 months of screening.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Donation of blood
Item
Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication
boolean
C0005794 (UMLS CUI [1])
Recent use of tobacco
Item
Subject has a history of tobacco use within 30 days of screening.
boolean
C0543414 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components
Item
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0272285 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1521826 (UMLS CUI [3,2])