Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

Future University in Egypt

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Copegus® 200 mg film coated tablet (2*200mg); Drug: Ribavirin 400 mg film coated tablet (1*400mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT05532306

RIB-B-20-028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Test product (T)

Experimental group

Description:

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

Treatment:

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

Reference product (R)

Active Comparator group

Description:

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

Treatment:

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