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A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine Modified Release (MR) when Co-administered or Administered Alone in Healthy Subjects

A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine Modified Release (MR) when Co-administered or Administered Alone in Healthy Subjects

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001012864
Enrollment
48
Registered
2012-09-19
Start date
2012-10-30
Completion date
2013-02-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A 2-Part, Single-Dose Study to Evaluate the Interaction of Etoricoxib and Tizanidine MR when Co-administered or Administered Alone in Healthy Subjects 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

Treatment A: Co-administration of a single oral dose of etoricoxib 90mg (tablet) and tizanidine MR 6mg (capsule) Treatment B: Administration of a single oral dose of etoricoxib 90mg (tablet) alone Treatment C: Administration of a single oral dose of tizanidine MR 6mg (capsule) alone All participants will receive single oral doses of each treatment in a 3 way crossover fashion with a minimum of 7 day washout period in between. MK0663B (combination treatment) is being developed for the treatm

Treatment A: Co-administration of a single oral dose of etoricoxib 90mg (tablet) and tizanidine MR 6mg (capsule) Treatment B: Administration of a single oral dose of etoricoxib 90mg (tablet) alone Treatment C: Administration of a single oral dose of tizanidine MR 6mg (capsule) alone All participants will receive single oral doses of each treatment in a 3 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.
Lead SponsorCommercial sector/Industry

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 -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

Source: ANZCTR · Data processed: Feb 4, 2026