Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

NCT05197517 | Completed Phase 1

• 1 other identifier: VIN-B-20-026
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence

Keywords

Rosuvastatin; Bioequivalence; Randomized; Cross-Over

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration (Cmax)

  Cmax is observed as the maximum of Rosuvastatin peak concentration

  Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours

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

  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).

  Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours

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

  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")

  Pre-dose to infinite time

Secondary Outcomes (3)

• Maximum time (Tmax)

  Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours

• Elimination Rate Constant (Kel)

  Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours

• Plasma concentration half-life (t1/2)

  Pre-dose and 0.5, 1, 2, 2.5, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 6, 7, 10, 12, 24, 48, and 72 hours

Study Arms (2)

Rosuvastatin 10 mg film coated tablets

EXPERIMENTAL

Single oral dose of 1 tablet (10 mg)

Drug: Rosuvastatin 10 mg

Crestor® 10 mg film coated tablets

ACTIVE COMPARATOR

Single oral dose of 1 tablet (10 mg)

Drug: Rosuvastatin 10 mg

Interventions

Rosuvastatin 10 mg DRUG

Film Coated Tablets products containing 10 mg Rosuvastatin

Crestor® 10 mg film coated tablets; Rosuvastatin 10 mg film coated tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rania Mahmoud Mohamed: lead
• Future University in Egypt: collaborator

Study Sites (1)

Future Research Center (FRC)

Cairo, Egypt

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Unit director at FRC

Model Details: A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: September 21, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

EG (1)