Back to resultsBioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition
Primary Purpose
Healthy Subjects
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ribavirin 400 mg film coated tablet (1*400mg)
Copegus® 200 mg film coated tablet (2*200mg)
Sponsored by
About this trial
This is an interventional health services research trial for Healthy Subjects focused on measuring Bioequivalence, Randomized, Crossover, Ribavirin
Eligibility Criteria
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.
Sites / Locations
- Future Research Center (FRC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test product (T)
Reference product (R)
Arm 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
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
Outcomes
Primary Outcome Measures
Maximum plasma concentration (Cmax)
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)
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
Maximum time (Tmax)
Time until Cmax is reached
Full Information
NCT ID
NCT05532306
First Posted
September 4, 2022
Last Updated
September 7, 2022
Sponsor
Future University in Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05532306
Brief Title
Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition
Official Title
A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Ribavirin From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2020 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
Keywords
Bioequivalence, Randomized, Crossover, Ribavirin
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test product (T)
Arm Type
Experimental
Arm 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
Arm Title
Reference product (R)
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Ribavirin 400 mg film coated tablet (1*400mg)
Other Intervention Name(s)
Test product (T)
Intervention Description
an immediate release film-coated tablet containing 400 mg Ribavirin
Intervention Type
Drug
Intervention Name(s)
Copegus® 200 mg film coated tablet (2*200mg)
Other Intervention Name(s)
Reference product (R)
Intervention Description
an immediate release film-coated tablet containing 200 mg Ribavirin
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Cmax is observed as the maximum of Ribavirin peak concentration
Time Frame
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
Title
Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)
Description
The AUC (0-72h) is the area under the plasma concentration with time curve from the time of dosing to the 72-hour sample
Time Frame
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 Outcome Measure Information:
Title
Maximum time (Tmax)
Description
Time until Cmax is reached
Time Frame
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Masoud, PhD
Organizational Affiliation
Future Research Center (FRC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Future Research Center (FRC)
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
11835
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months following article publication and no end date
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to <hala.fut.masoud@gmail.com> To gain access.
Learn more about this trial
Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition
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