Bioequivalence Assessment of Topical Smartech 2% Diclofenac Sodium Solution Compared to a Reference Product When Applied to the Knees of Healthy Male and Female Participants

This study will investigate the bioequivalence of Smartech Formulation 2 when compared with a reference product (either Pennsaid 2% diclofenac or a generic diclofenac 2%) as described below: Group 1: Participants who were treated with Pennsaid and were included in the study PK population in the SMTPK001 study (ACTRN12622001391763), and to whom only Smartech Formulation 2 will be administered in this study Group 2: Participants who were not treated in the SMTPK001 study (ACTRN12622001391763), and to whom Smartech Formulation 2 and generic diclofenac 2% will be administered in this study following a crossover design, with a washout period between treatments of at least 14 days and up to 17 days. Smartech Formulation 2 (diclofenac sodium topical solution) 2 percent weight for weight (w/w) is a topical non-steroidal anti-inflammatory drug. Two pump actuations (2mL, equivalent to 40mg diclofenac) will be applied to each knee, twice daily for 7.5 days. On Day 8 of the study, two pump actuations (2mL equivalent to 40mg diclofenac) will be applied once. The investigational product will be applied to both knees, within an area of 10cm above and below the knee, front and back by a clinical trial nurse. All doses will be applied while the participant is a resident of the clinical trial unit. The clinical trial nurse will actuate the pump onto the hand and apply the product to the participant knees. One knee will be dosed and then the other ensuring two pumps are applied fully to each knee. The knees will be allowed to dry before clothing or bed linen are allowed to touch the area of application. In Group 2, a washout period of at least 14 days and up to 17 days is scheduled between the dosing periods of Smartech Formulation 2 and the reference generic product.