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Completed

NCT Number: NCT05235230

Partially Replicate Bioequivalence Study of Quetiapine 25 mg in Healthy Volunteers Under Fasting Condition

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.

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Key information

Conditions

Bioequivalence

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Future Research Center (FRC)

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test product (T) 25 mg Film Coated Tablets

Drug

Film Coated Tablets products containing 25 mg Quetiapine

Reference product (R) 25 mg Film Coated Tablets

Drug

Reference product (R) 25 mg Film Coated Tablets

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 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

  2. Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))

    Time frame: 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)

  3. Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))

    Time frame: 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 outcomes

  1. Maximum time (Tmax)

    Time frame: 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

  2. Elimination Rate Constant (Kel)

    Time frame: 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

  3. Plasma concentration half-life (t1/2)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

A Randomized, Single-dose, Partial Replicate, Three-phase, Three-sequence, Open-label, Bioequivalence Study Comparing Quetiapine 25 mg in Different Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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