Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-45
SponsorYung Shin Pharm. Ind. Co., Ltd.
About this trial
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of parecoxib after intravenous bolus of parecoxib in healthy volunteers under fasting conditions
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
no particular clinically significant abnormalities in Electrocardiogram (ECG) results within six months prior to Period I dosing.
no particular clinical significance in general disease history within two months prior to Period I dosing.
Disqualifiers
A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
A clinically significant illness or surgery within four weeks prior to Period I dosing.
History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
Trial design
Design model
Crossover
Treatments tested in this trial
Parecoxib
DrugPharmacokinetic study under fasting conditions
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: Reference DrugActive comparator 1 intervention
Group B: Test DrugExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Peak plasma concentration (Cmax)
Time frame
0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)2
Area under the concentration-time curve from time zero to time of last quantifiable
Time frame
0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)3
Area under the concentration-time curve from time zero to infinity (AUC 0-∞)
Time frame
0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)Sponsors and contacts
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Source ClinicalTrials.gov
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