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A pharmacokinetic study to compare the bioavailability between MK-0663 (etoricoxib ) 120 mg Tablets from Two Different Manufacturing Sites (Frosst Iberica, Spain versus Elkton, VA, USA).

A pharmacokinetic study to compare the bioavailability between MK-0663 (etoricoxib ) 120 mg Tablets from Two Different Manufacturing Sites (Frosst Iberica, Spain versus Elkton, VA, USA). - MK-0663 (CS0177)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37397
Enrollment
24
Registered
2012-02-16
Start date
2012-02-23
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

arthrosis rheumatism

Interventions

The study will start with a screening. A few standard medical assessments will be performed (physical examination, ECG, vital signs). Furthermore a blood and urine sample will be taken for laborator

Sponsors

Merck Sharp & Dohme (MSD)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female, between 18-55 years of age, BMI 18-30.

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

MeasureTime frame
To determine the relative bioavailability of etoricoxib 120 mg tablets manufactured at Frosst Iberica, Spain and Elkton, VA, USA.

Secondary

MeasureTime frame
To evaluate the safety and tolerability of a single dose of 120 mg etoricoxib manufactured at Frosst Iberica, Spain and Elkton, VA, USA, in healthy adults.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)