NCT05197517

Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the Two Different Products Containing 10 mg Film Coated Tablet After Oral Administration to 38 Healthy Adult Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Rania Mahmoud Mohamed · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.

Detailed description

A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteers under fasting conditions. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Plasma concentrations of Rosuvastatin were analyzed and determined using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Rosuvastatin 10 mg	Film Coated Tablets products containing 10 mg Rosuvastatin

Timeline

• Start date: 2020-09-21
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2022-01-19
• Last updated: 2022-01-20

Locations

1 site across 1 country: Egypt