Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

NCT ID: NCT05197517

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2020-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Rosuvastatin 10 mg film coated tablets

Single oral dose of 1 tablet (10 mg)

Group Type: EXPERIMENTAL

Rosuvastatin 10 mg

Intervention Type: DRUG

Film Coated Tablets products containing 10 mg Rosuvastatin

Crestor® 10 mg film coated tablets

Single oral dose of 1 tablet (10 mg)

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 10 mg

Intervention Type: DRUG

Film Coated Tablets products containing 10 mg Rosuvastatin

Interventions

Rosuvastatin 10 mg

Film Coated Tablets products containing 10 mg Rosuvastatin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Future University in Egypt

OTHER

Sponsor Role: collaborator

Rania Mahmoud Mohamed

OTHER

Sponsor Role: lead

Responsible Party

Rania Mahmoud Mohamed

Unit director at FRC

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Future Research Center (FRC)

Cairo, , Egypt

Countries

Egypt

Other Identifiers

VIN-B-20-026

Identifier Type: -

Identifier Source: org_study_id