Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

NCT05532306 | Completed Phase 1

• 1 other identifier: RIB-B-20-028
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Ribavirin 400 mg, after administering a single oral dose, to healthy adult subjects under fed conditions.

Conditions

Healthy Subjects

Keywords

Bioequivalence; Randomized; Crossover; Ribavirin

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax)

  Cmax is observed as the maximum of Ribavirin peak concentration

  Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose

• Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)

  The AUC (0-72h) is the area under the plasma concentration with time curve from the time of dosing to the 72-hour sample

  Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose

Secondary Outcomes (1)

• Maximum time (Tmax)

  Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose

Study Arms (2)

Test product (T)

EXPERIMENTAL

Subjects were served a standardized high caloric meal 30 minutes before the administration of a single film-coated tablet containing 400 mg Ribavirin (1\*400mg) with approximately 240 ml of water

Drug: Ribavirin 400 mg film coated tablet (1*400mg)

Reference product (R)

ACTIVE COMPARATOR

Subjects were served a standardized high caloric meal 30 minutes before the administration of two film-coated tablets each containing 200 mg Ribavirin (2\*200mg) with approximately 240 ml of water

Drug: Copegus® 200 mg film coated tablet (2*200mg)

Interventions

Ribavirin 400 mg film coated tablet (1*400mg) DRUG

an immediate release film-coated tablet containing 400 mg Ribavirin

Also known as: Test product (T)

Test product (T)

Copegus® 200 mg film coated tablet (2*200mg) DRUG

an immediate release film-coated tablet containing 200 mg Ribavirin

Also known as: Reference product (R)

Reference product (R)

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 the 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 of 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

• Future University in Egypt: lead

Study Sites (1)

Future Research Center (FRC)

Cairo, New Cairo, 11835, Egypt

Location

MeSH Terms

Interventions

Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hala Masoud, PhD

  Future Research Center (FRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FRC Technical Director & CEO

Model Details: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: October 11, 2020
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months following article publication and no end date
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to \<hala.fut.masoud@gmail.com\> To gain access.

Locations

EG (1)