The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness (DOMS).~Healthy volunteers will be recruited to undergo a controlled exercise test designed to induce DOMS in lower limbs. Subjets reporting sufficient pain intensity while walking in an 11-point Numerical Rating Scale (NRS) 24h or 48 h after exercise will be randomized to receive treatment with Comboprofen, placebo, ibuprofen, magnesium or vitamin c three times a day (TID) for 3 days.~Once a subject is randomized the duration of participation will be 7 days. Subjects will be housed in the clinic for the first 24 hours of dosing. Pain intensity while standing up and sitting down and while walking will be assessed throughout the study using an 11-point (0-10) Numeric Rating Scale (NRS). Maximal isometric force, muscle damage and inflammatory markers will be also assessed throughout the study.
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness (DOMS).