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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05532306
Other study ID # RIB-B-20-028
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 11, 2020
Est. completion date November 23, 2020

Study information

Verified date September 2022
Source Future University in Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 23, 2020
Est. primary completion date November 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Ribavirin 400 mg film coated tablet (1*400mg)
an immediate release film-coated tablet containing 400 mg Ribavirin
Copegus® 200 mg film coated tablet (2*200mg)
an immediate release film-coated tablet containing 200 mg Ribavirin

Locations

Country Name City State
Egypt Future Research Center (FRC) Cairo New Cairo

Sponsors (1)

Lead Sponsor Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Maximum time (Tmax) Time until Cmax is reached 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
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