The primary objective(s) of this study is:- To determine the relative bioavailability of etoricoxib 120 mg tablets manufactured at Frosst Iberica, Spain and Elkton, VA, USA.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the relative bioavailability of etoricoxib 120 mg tablets
manufactured at Frosst Iberica, Spain and Elkton, VA, USA.
Secondary outcome
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.
Background summary
Etoricoxib tablets are currently manufactured at Elkton, VA, USA, but a site
transfer will take place to Frosst Iberica, Spain. The regulatory authorities
of Taiwan require a bioequivalence assessment to support such changes. Hence,
the current study is being conducted to establish bioequivalence between
etoricoxib 120 mg tablets manufactured at Frosst Iberica, Spain and Elkton, VA,
USA.
Study objective
The primary objective(s) of this study is:
- To determine the relative bioavailability of etoricoxib 120 mg tablets
manufactured at Frosst Iberica, Spain and Elkton, VA, USA.
Study design
This is an open-label, randomized 2-period crossover study to assess the in
vivo pharmacokinetics of 120 mg etoricoxib tablets manufactured at Frosst
Iberica, Spain and Elkton, VA, USA, conducted at one site with healthy
volunteers.
Intervention
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 laboratory tests and an alcohol breath test and
drug screen will be done.
During the stay in the clinic (two times) the subject will receive the study
medication and on several time points blood will be taken. The subjects will be
asked for possible side effects on regular basis. Furthermore safety
assessments will be done frequently.
During the ambulant visits (8 times) blood will be taken and the subjects will
be asked for possible side effects.
Study burden and risks
Etoricoxib is a registered drug that is well tolerated. However, as with any
medicine, it is possible that etoricoxib can cause side-effects.
In several clinical studies in which patients with osteoarthritis, rheumatoid
arthritis, chronic low back pain and acute pain received one daily dose of
Etoricoxib for 1 to 12 days, the following side effects occurred:
asthenia/fatique, dizziness, swelling of the legs and/or feet due to oedema,
hypertension, heartburn, nausea, headache and changes in the results of a
bloodtest for the liver.
The dose level that is used in this study is the highest dose level that is
prescribed to patients. The risk to the above mentioned side effects is limited
since the dose level is administered as a single dose in each treatment period,
but the subjects may experience one of the above mentioned side-effects or
other symptoms not previously reported. The health of the subjects will be
closely monitored during the trial to minimize these risks.
The blood collection procedure may cause discomfort or bruising. Occasionally,
fainting or an infection at the blood sampling site can occur.
Molenstraat 110
5340 BH Oss
NL
Molenstraat 110
5340 BH Oss
NL
Listed location countries
Age
Inclusion criteria
Male and female, between 18-55 years of age, BMI 18-30.
Exclusion criteria
Clinical significant abnormalities at medical research
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000549-11-NL |
| CCMO | NL39810.056.12 |