Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition
- Conditions
- Bioequivalence
- Interventions
- Drug: Test product (T) 40 mg Hard Gelatin CapsulesDrug: Reference product (R) 40 mg Hard Gelatin Capsules
- Registration Number
- NCT05235217
- Lead Sponsor
- Future University in Egypt
- Brief Summary
The current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions.
- Detailed Description
A randomized, single-dose, two-treatment, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Esomeprazole plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
- Written informed consent is obtained for study.
- Age 18 - 55 years,
- Body mass index between 18.5 and 30 kg/m2
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
- Vital signs without significant deviations.
- All laboratory screening results are within the normal range or clinically non-significant
- History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
- History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
- Any confirmed significant allergic reactions against any drug, or multiple allergies.
- Clinically significant illness 28 days before study period I.
- Alcohol or any solvent intake.
- Regular use of medication.
- Positive urine screening of drugs of abuse.
- Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
- History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
- Blood donation within the past 60 days.
- Participation in another bioequivalence study within 60 days prior to the start of period I of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test product (T) 40 mg Hard Gelatin Capsules Test product (T) 40 mg Hard Gelatin Capsules Single oral dose of 40 mg capsule Reference product (R) 40 mg Hard Gelatin Capsules (first dose) Reference product (R) 40 mg Hard Gelatin Capsules Single oral dose of 40 mg capsule Reference product (R) 40 mg Hard Gelatin Capsules (second dose) Reference product (R) 40 mg Hard Gelatin Capsules Single oral dose of 40 mg capsule
- Primary Outcome Measures
Name Time Method Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf)) Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose AUC(0-inf) "the area under the curve," which is a way of measuring the total amount of the active drug in a subject's system over a period of time from administration ("0") to the time that the drug is no longer present in the subject's body ("infinity")
Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t)) Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose The AUC (0-t) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast)
Maximum plasma concentration (Cmax) Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose Cmax is observed as the maximum of Esomeprazole peak concentration
- Secondary Outcome Measures
Name Time Method Maximum time (Tmax) Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose Time until Cmax is reached
Elimination Rate Constant (Kel) Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose Kel is a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system
Plasma concentration half-life (t1/2) Pre-dose (0) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 , 6 , 8 , 10 , 12 and 24 hours post dose t1/2 is the time taken for the plasma concentration of a drug to reduce to half its original value. It is used to estimate how long it takes for a drug to be removed from your body.
Trial Locations
- Locations (1)
Future Research Center (FRC)
🇪🇬Cairo, Egypt