Healthy SubjectsPhase 1NCT05532306
Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition
A Phase 1 study testing Ribavirin 400 mg film coated tablet (1*400mg) and Copegus® 200 mg film coated tablet (2*200mg) in people with Healthy Subjects, run by Future University in Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Ribavirin 400 mg film coated tablet (1*400mg) and Copegus® 200 mg film coated tablet (2*200mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2020to 23 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Ribavirin 400 mg film coated tablet (1*400mg), Copegus® 200 mg film coated tablet (2*200mg)
- Keywords
- Bioequivalence, Randomized, Crossover, Ribavirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribavirin 400 mg film coated tablet (1*400mg)Drug
Also called Test product (T)
an immediate release film-coated tablet containing 400 mg Ribavirin
Copegus® 200 mg film coated tablet (2*200mg)Drug
Also called Reference product (R)
an immediate release film-coated tablet containing 200 mg Ribavirin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Copegus® 200 mg film coated tablet (2*200mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Ribavirin peak concentration
Measured: 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
Measured: 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)
Time until Cmax is reached
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start11 Oct 2020
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Masoud, Future University in Egypt
- Investigators
- Hala Masoud, PhD, Principal investigator, Future Research Center (FRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532306
- Sponsor's protocol ID
- RIB-B-20-028
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05532306
- Acronym / sponsor ID
- RIB-B-20-028
- Conditions
- Healthy Subjects
- Keywords
- Bioequivalence, Randomized, Crossover, Ribavirin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Test product (T) | Experimental | Drug: 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) | Active comparator | Drug: 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ribavirin 400 mg film coated tablet (1*400mg)Also: Test product (T)an immediate release film-coated tablet containing 400 mg Ribavirin | Drug | Test product (T) |
| Copegus® 200 mg film coated tablet (2*200mg)Also: Reference product (R)an immediate release film-coated tablet containing 200 mg Ribavirin | Drug | Reference product (R) |
Primary outcome
Maximum plasma concentration (Cmax)
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
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)
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
The AUC (0-72h) is the area under the plasma concentration with time curve from the time of dosing to the 72-hour sample
1 secondary outcome
Maximum time (Tmax)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Masoud, PhD principal investigator
Future Research Center (FRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ribavirin 400 mg film coated tablet (1*400mg) and Copegus® 200 mg film coated tablet (2*200mg) in people with Healthy Subjects, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.