Bioequivalence
Conditions
Keywords
Quetiapine, Replicate, Randomized
Brief summary
The current study is conducted to evaluate and compare the relative bioavailability for Quetiapine in two different products containing 25 mg Quetiapine after a single oral dose administration under fasting conditions.
Detailed description
A randomized, single-dose, 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. Quetiapine 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.
Interventions
DRUGTest product (T) 25 mg Film Coated Tablets
Film Coated Tablets products containing 25 mg Quetiapine
DRUGReference product (R) 25 mg Film Coated Tablets
Reference product (R) 25 mg Film Coated Tablets
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A randomized, single-dose, partial replicate crossover, three-phase, three-sequence, two treatments bioequivalence study
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 phase 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 phase I of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose | Cmax is observed as the maximum of Quetiapine peak concentration |
| Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t)) | Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 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) |
| Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf)) | Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum time (Tmax) | Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose | Time until Cmax is reached |
| Elimination Rate Constant (Kel) | Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 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), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 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. |
Countries
Egypt
Outcome results
None listed