NCT05235230

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Future University in Egypt · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Test product (T) 25 mg Film Coated Tablets	Film Coated Tablets products containing 25 mg Quetiapine
DRUG	Reference product (R) 25 mg Film Coated Tablets	Reference product (R) 25 mg Film Coated Tablets

Timeline

• Start date: 2021-05-19
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2022-02-11
• Last updated: 2022-02-11

Locations

1 site across 1 country: Egypt