Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

Rania Mahmoud Mohamed

Status and phase

Completed

Phase 1

Conditions

Bioequivalence

Treatments

Drug: Rosuvastatin 10 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05197517

VIN-B-20-026

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.