None listed
Conditions
Brief summary
An open-label, 2-part, randomized, single-dose, crossover study to initially characterize the pharmacokinetics, safety, and tolerability of MK-0663B 90 mg/6 mg formulated as prototype tablets under fasted and fed conditions when compared to coadministration of the individual components. The change in pharmacokinetics for etoricoxib and tizanidine when administered under fasting (Part 1) and fed conditions (Part 2) will be characterized. MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.
Interventions
PART 1
Three fixed dose combination formulation prototypes will be compared to co-administration of the marketed formulations. The difference between the 3 prototypes for part 1 are different rates of dissolution.
Treatment A: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 1)
Treatment B: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 2)
Treatment C: Administration of a single oral dose of MK
PART 1 Three fixed dose combination formulation prototypes will be compared to co-administration of the marketed formulations. The difference between the 3 prototypes for part 1 are different rates of dissolution. Treatment A: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 1) Treatment B: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 2) Treatment C: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 3) Treatment D: Co-administration of a single oral dose of etoricoxib 90 mg & tizanidine MR 6 mg All participants will receive single oral doses of each treatment in a 4 way crossover fashion with a minimum of 7 day washout period in between. PART 2 The prototype most closely approximating co-administration of etoricoxib 90 mg & tizanidine MR 6 mg will be selected for Part 2. Treatment E: Administration of a single oral dose of MK-0663B (Prototype selected from Part 1) Treatment F: Co-administration of a single oral dose of etoricoxib 90 mg & tizanidine MR 6 mg All participants will receive single oral doses of each treatment in a 2 way crossover fashion with a minimum of 7 day washout period in between. MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.
Sponsors
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
-BMI < 30kg/m2 -Female of reproductive potential to have negative pregnancy test and agree to use double-barrier contraception -Good health based on medical history, physical examination, vital sign measurements, ECG and laboratory assessments -Non smoker
Exclusion criteria
-History of emotional problems or clinically significant psychiatric disorder within 5yrs -Clinically significant disease/disorder of any body systems -Creatinine clearance of <80mL/min -History of neoplastic disease -Breast feeding mother -History of stroke, chronic seizures or major neurological disorder -Current use of prescription/non-prescription medication (includes oral contraception)-Consumes excessive amounts of alcohol -Consumes excessive amounts of caffeine -History of significant or severe allergies or anaphylactic reaction -History of serious adverse experiences related to non-steroidal anti-inflammatory drug -Regular user of illicit drugs
Outcome results
None listed