None listed
Conditions
Interventions
Intervention1: Diclofenac sodium patches: 15 mg using one 7x10 cm 15 mg patch 30 mg using two 7x10 cm 15 mg patch 60 mg using four 7x10 cm 15 mg patch 30 mg using one 10x14 cm 30 mg patch
Control In
Sponsors
Cerimon Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female volunteers aged 18 - 75 years 2. Provide written informed consent to participate in all aspects of the study 3. Have a negative urine pregnancy test result, prior to study entry, for all female subjects of childbearing potential 4. Use an effective birth control method and a willingness to continue birth control during the study and for 2 weeks following the study, for female subjects of childbearing potential
Exclusion criteria
Exclusion criteria: 1. A history of intolerance or hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) 2. A history of hypersensitivity to Diclofenac or Diclofenac-containing products 3. A history of asthma within 1 year of study entry 4. A history of peptic ulcer within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder (with the exception of bleeding due to internal or external hemorrhoids) 5. Current smoker or history of smoking within 6 months of study entry 6. Clinically significant active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease 7. Clinically significant abnormal clinical laboratory test results during screening period 8. Positive test result for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) 9. Allergy to adhesives (e.g. adhesive tape) 10. Topical lotions, creams or gels applied to the application site within 7 days prior to randomization 11. Active skin disease involving the back (general area where patch(es) will be applied) 12. Excessive hair, abrasion, irritation, bruising, scarring or other damage to the skin of the back area 13. Any medications including prescription, over-the-counter and herbal products within 30 days prior to dosing. If any medication has been used infrequently during this window, the sponsor will be contacted to determine eligibility. 14. Positive urine drug screen for any drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) 15. Positive alcohol breath test. Subjects will be instructed to refrain from alcohol use for at least 48 hours prior to screening, and during confinement/dosing period and follow-up period. 16. Treatment with an investigational drug or device within 30 days before study entry 17. Treatment with an investigational biologic within 6 months before study entry 18. Blood donation within 30 days of enrollment 19. Any ECG abnormalities unless approved by the Medical Monitor 20. Pregnant or breast-feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: To assess and compare the systemic and topical safety and tolerability of the topical patch formulation application.Timepoint: 4 days;Safety: To assess and compare the systemic and topical safety and tolerability of the topical patch formulation application.Timepoint: 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Siddangouda Patil
Outcome results
None listed