Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets

1. History of hypersensitivity, allergy, intolerance or contraindication to the use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma

2. History or presence of cardio-or cerebrovascular disease; e.g., diabetes, hypertension, hyperlipidemia

3. History or presence of congenital heart disease, cardiac arrhythmias requiring medication, or a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in the study

4. History or evidence of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or sign/symptoms consistent with any of the above

5. History or evidence of central nervous system pathology including stroke and/or transient ischemic attacks, epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening

6. History or evidence of impaired hepatic or renal function or any screening laboratory assessment that is clinically significant in the investigator's opinion

7. Has clinically significant allergic disease (excluding non-active hay fever) or a history of multiple drug allergies

8. Evidence of macrocytic or microcytic anemia or deficiency of folate or B12 at Screening

9. Blood donation in excess of: 500 mL in 14 days; 1,500 mL in 180 days or 2,500 mL in one year

10. History of any bleeding disorder

11. Gastrointestinal disorder, surgery, ulceration, or perforation in the past 6 months; gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease

12. Females actively trying to become pregnant or breast feeding

13. History or evidence of alcohol abuse (more than 28 units of alcohol (male) or 21 units of alcohol (female) per week) or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicate participation in this clinical trial

14. Participated in a investigational drug trial within the previous four weeks

15. Used tobacco products within the past year

16. Has taken any medication, including over-the counter, prescription, herbal remedies, within one month of the first dose (with the exception of vitamin/mineral supplements)

17. Is currently working or living in an environment that exposes subject to cytotoxic chemicals or ionizing radiation, or subject has had any medical X-Ray, vaccination, or significant viral or bacterial illness within one month of Screening

18. Body Mass Index outside the range of 19-32 kg/m2 at Screening

19. Presence or history of any malignancy

What this study is about