Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Ribavirin 400 mg film coated tablet (1*400mg); Drug: Copegus® 200 mg film coated tablet (2*200mg)

• Registration Number: NCT05532306
• Lead Sponsor: Future University in Egypt

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.

Detailed Description

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) each phase, under fed conditions, with a wash-out period of 42 days.

Ribavirin plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Study Timeline

• Study Start: 2020-10-11
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23
• Status Verified: 2022-09
• Study First Submitted: 2022-09-04
• Study First Submitted QC: 2022-09-07
• Last Update Submitted: 2022-09-07
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• 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

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test product (T)	Ribavirin 400 mg film coated tablet (1*400mg)	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
Reference product (R)	Copegus® 200 mg film coated tablet (2*200mg)	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

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	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	Cmax is observed as the maximum of Ribavirin peak concentration
Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)	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	The AUC (0-72h) is the area under the plasma concentration with time curve from the time of dosing to the 72-hour sample

Secondary Outcome Measures

Name	Time	Method
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	Time until Cmax is reached

Trial Locations

Locations (1)

Future Research Center (FRC); 🇪🇬 Cairo, New Cairo, Egypt