1. Healthy, non-smoking, male and female subjects, 18 years of age or older.
2. BMI â‰¥ 18.5 and 30.0 kg/m2
3. No clinically significant findings in vital signs measurements.
4. No clinically significant abnormal laboratory values.
5. No clinically significant findings in a 12-lead electrocardiogram (ECG).
6. No significant diseases.
7. Willing to use an acceptable, effective method of contraception.
8. Be informed of the nature of the study and give written consent prior to any study
9. Have no clinically significant findings from a physical examination.
1. Known history or presence of any clinically significant medical condition.
2. Known or suspected carcinoma.
3. History or presence of ulcerative colitis, diverticulosis, Crohn's disease, or
gastrointestinal ulcer, perforation, or haemorrhage.
4. Known history or presence of auto-immune disorders, gastrointestinal toxicity, or a
risk of gastrointestinal bleeding or gastrointestinal tract irritation.
5. Known history or presence of cardiovascular disease, heart failure, tachycardia,
hypertension, angina pectoris, hyperthyroidism, psychosis, seizures, risk of urinary
retention, diabetes, phaeochromocytoma, closed angle glaucoma, chronic rhinitis, or
6. Known history or presence of angioedema.
7. Known history or presence of galactose or fructose intolerance, sucraseisomaltase
insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose
8. Known history of severe skin reactions (e.g. exfoliative dermatitis, SJS, and TEN).
9. Known history or presence of bronchial asthma or allergic disease resulting in
10. Presence of hepatic or renal dysfunction.
11. Presence of clinically significant gastrointestinal disease or history of
malabsorption within the last year.
12. Presence of a medical condition requiring regular medication (prescription and/or
over-the-counter) with systemic absorption.
13. History of drug or alcohol addiction requiring treatment.
14. History of gastrointestinal bleeding or perforation when previously taking NSAIDs.
15. Positive test result for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
16. Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines,
cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone and
benzodiazepines) or urine cotinine.
17. Difficulty fasting or consuming standard meals.
18. Does not tolerate venipuncture.
19. Use of tobacco or nicotine-containing products within 6 months prior to drug
20. On a special diet within 30 days prior to drug administration (e.g., liquid, protein,
raw food diet).
21. Participated in another clinical trial or received an investigational product within
30 days prior to drug administration.
22. Donation or loss of whole blood (including clinical trials):
- 50 mL and â‰¤ 499 mL within 30 days prior to drug administration
- 500 mL within 56 days prior to drug administration.
23. Females who:
Have discontinued or changed the use of implanted, intrauterine, intravaginal, or
injected hormonal contraceptives within 6 months prior to dosing; Have discontinued or
changed the use of oral or patch hormonal contraceptives within 1 month prior to drug
administration; Are pregnant (serum hCG consistent with pregnancy); or Are lactating.
24. Have had a tattoo or body piercing within 30 days prior to drug administration.
25. Known history or presence of hypersensitivity or idiosyncratic reaction to ibuprofen,
pseudoephedrine, NSAIDs, or any other drug substances with similar activity or any of
the excipients in the drug products
26. Use of drugs in the phenethylamine and amphetamine chemical classes within 14 days
prior to drug administration.
27. Use of NSAIDs (including cyclo-oxygenase-2 selective inhibitors) aspirin,
corticosteroids, anticoagulants, selective serotonin-reuptake inhibitors,
antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, cyclosporin,
mifepristone, tacrolimus, zidovudine, linezolid, dopaminergic alkaloids, quinolone
antibiotics, terpene derivatives, clobutinol, atropine, local anaesthetics, MAO
inhibitors, vasoconstrictors, alpha sympathomimetic drugs, or anti-platelet agents
within 30 days prior to drug administration.
28. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days
prior to drug administration. (e.g. barbiturates, carbamazepine, phenytoin,
glucocorticoids, omeprazole, antidepressants (SSRI), cimetidine, diltiazem,
macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines).