Healthy, non-smoking adult males and females between 18 and 55 years of age
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])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Pregnancy and contraceptive methods
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, • Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or • Any other method with published data showing that the lowest expected failure rate is less than 1PERCENT per year.
boolean
C0427780 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
Stable regimen of hormone treatment
Item
Any subject taking oral contraceptives or hormone replacement therapy (HRT) has been on a stable regimen for at least 2 months prior to screening.
boolean
C0279025 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
BMI
Item
BMI: 20-30 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Informed consent
Item
Subject is willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
History of impaired hepatic or renal function
Item
History of impaired hepatic or renal function.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Current migraine diagnosis
Item
Subjects with a current migraine diagnosis.
boolean
C0149931 (UMLS CUI [1])
Confirmed or suspected Ischemic heart disease such as angina pectoris, Prinzmetal’s angina
Item
Subject has confirmed or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal’s angina or signs/symptoms consistent with any of the above.
boolean
C0151744 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0002963 (UMLS CUI [3])
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 clinically significant electrocardiogram 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])
C0522055 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C1301624 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Congenital heart disease
Item
Subject has a history of congenital heart disease.
boolean
C0152021 (UMLS CUI [1])
History of cerebrovascular pathology including stroke
Item
Subject has a history of cerebrovascular pathology including stroke
boolean
C0007820 (UMLS CUI [1])
C0559159 (UMLS CUI [2])
Likely to have unrecognized cardiovascular or cerebrovascular disease
Item
The subject, in the investigator’s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
boolean
C0007222 (UMLS CUI [1,1])
C4288068 (UMLS CUI [1,2])
C0007820 (UMLS CUI [2,1])
C4288068 (UMLS CUI [2,2])
Infection status of hepatitis B, hepatitis C and HIV
Item
Subject has a positive hepatitis B surface antigen or hepatitis C antibody or HIV test within 84 days of the start of the study.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
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])
Uncontrolled hypertension
Item
Subject has uncontrolled hypertension at screening (sitting systolic pressure >= 140mm/Hg, diastolic pressure >= 90mm/Hg).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
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])
Current or recent treatment with a monoamine oxidase inhibitor (MAOI)
Item
Subject is currently taking a monoamine oxidase inhibitor (MAOI) or has taken a MAOI within the 2 weeks prior to screening.
boolean
C0026457 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0026457 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements
Item
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days (14 days for St John's wort) prior to the first dose of study medication.
boolean
C0013231 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
Positive serum beta-hCG test
Item
Positive serum beta-human chorionic gonadotropin (beta-hCG) test (females).
boolean
C1255526 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Pregnant or nursing females
Item
Pregnant or nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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])
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])
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
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.
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])
Hypersensitivity to naproxen and/or aspiring or other nsaid drugs
Item
History of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the symdrome of asthma, rhinitis and nasal polyps.
boolean
C0020517 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0003211 (UMLS CUI [3,2])
Gastrointestinal surgery due to bleeding, ulceration or perforation
Item
History of 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
History of gastric bypass or stapling surgery.
boolean
C0149701 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
History of GI ulceration or gastrointestinal bleeding
Item
History of GI ulceration or gastrointestinal bleeding.
boolean
C1963975 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
History of bleeding disorder
Item
History of any bleeding disorder.
boolean
C0005779 (UMLS CUI [1])
History of inflammatory bowel disease
Item
History of inflammatory bowel disease.
boolean
C0021390 (UMLS CUI [1])
Treatment with anti-platelet agent (except low-dose aspirin)
Item
Taking anti-platlet agents (except low-dose aspirin < 325mg/day for cardioprotective reasons).
boolean
C0085826 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2608320 (UMLS CUI [1,3])
Taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers
Item
Taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers.
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [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])