Bioequivalence StudyPhase 1NCT03602300
A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study
A Phase 1 study testing Ravidasvir test formulation produced by Doppel and Ravidasvir reference formulation produced by EEPI in people with Bioequivalence Study, run by Drugs for Neglected Diseases at 1 site in Malaysia.
Trial summary
In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- Ravidasvir test formulation produced by Doppel and Ravidasvir reference formulation produced by EEPI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMalaysia
- Study dates
- 5 Jun 2018to 17 Aug 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- Must be between 18 and 55 years of age, inclusive.
- Must be a non-smoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug. Users of electronic cigarette are not allowed to participate in this study. A smokerlyzer test will be performed to estimate the amount of carbon monoxide in the breath.
- Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
- Must be HIV-1 antibody negative.
- Must be hepatitis B (HBV) surface antigen negative.
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- Must be hepatitis C (HCV) antibody negative.
- Females of childbearing potential must have a negative serum pregnancy test at Screening and on Day 0.
- Females of childbearing potential must agree to utilize highly effective contraception methods (with the exception of hormonal contraceptive) from 3 weeks prior to baseline (Day 0) throughout the duration of study treatment and for 30 days following the last dose of study drug. Female healthy volunteers who utilize hormonal contraceptive as one of their birth control methods are not allowed to participate in this study.
- Men who participate in this study must not father a child and must agree to use contraceptive protection in the form of a double barrier method (condom or diaphragm) from the moment they sign the ICF until the Post-Study Safety Assessment.
- Healthy volunteers must, in the opinion of the Investigator, be in good health based upon medical history, physical examination (including vital signs), and screening laboratory evaluations (haematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance.
- Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the Investigator.
- Must have negative urine screen for drugs of abuse (including ketamine, amphetamines, tetrahydrocannabinol, morphine, methamphetamine, and benzodiazepines)
- Must be willing and able to comply with all study requirements
Who cannot join
- Healthy volunteers with any hematologic or urinary analyte that is outside the normal limits of the study laboratory and have been determined by the Investigator to have clinical significance at Screening will be excluded
- Pregnant or lactating female healthy volunteers.
- Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
- Have participated in an investigational trial involving administration of any investigational compound within 90 days prior to the study dosing or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial).
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
- Have poor venous access and unable to donate blood.
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- Have donated or lost blood (≥500ml) within two months of study dosing.
- Have donated plasma within 7 days of study dosing.
- Have difficulty in swallowing solids like tablets.
- Have taken any prescription medications or over-the-counter medications including herbal products within 1 week of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen.
- Female healthy volunteers who utilize hormonal contraceptive as one of their birth control methods.
- Have a history of significant drug allergy.
- Smokers and users of electronic cigarette.
- Unable to comply with study requirements.
- Believed by the study Investigator to be inappropriate for study participation for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir in Healthy Adult Volunteers Under Fasting Conditions
In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both Cmax and AUC0-t.
A two-sequence, four-period replicate design will be used to allow the possibility to scale the acceptance range for Cmax if the observed intra-subject coefficient of variation for the reference formulation is greater than 30%
Read the detailed description
During the course of development, a new batch of ravidasvir tablets has been prepared by the proposed commercial manufacturer (Doppel Farmaceutici, Italy). Tablets manufactured by Doppel Farmaceutici are intended to be used in subsequent clinical trials and be registered as the commercial product. The purpose of this Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study is to assess if ravidasvir 200 mg tablets supplied by European Egyptian Pharmaceutical Industries (EEPI) and tablets from Doppel Farmaceutici are bioequivalent.
Primary objectives:
To compare the rate and extent of absorption for ravidasvir (RDV) when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.
Secondary objectives To evaluate the safety and tolerability of single oral doses of RDV in healthy volunteers.
- Conditions
- Bioequivalence Study
- Being tested
- Ravidasvir test formulation produced by Doppel, Ravidasvir reference formulation produced by EEPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ravidasvir test formulation produced by DoppelDrug
To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.
Ravidasvir reference formulation produced by EEPIDrug
To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Ravidasvir reference formulation | Active comparator | Ravidasvir 200 mg oral single dose manufactured by EEPI Receives: Drug: Ravidasvir reference formulation produced by EEPI |
| Ravidasvir test formulation | Experimental | Ravidasvir 200 mg oral single dose manufactured by Doppel Receives: Drug: Ravidasvir test formulation produced by Doppel |
What is being measured
The primary outcome is the main question the study is designed to answer.
RDV Plasma CMax when administered as a single 200 mg oral dose of the test versus reference product
Plasma RDV Cmax will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose
Measured: Measurement within 48 hours post-dose
RDV area under the plasma concentration-time curve from time of intake until infinity (AUC0-∞) when administered as a single 200 mg oral dose of the test versus reference product
Area under the plasma concentration-time curve from time of intake until infinity (AUC0-∞) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV area under the plasma concentration-time curve from time of intake until the last quantifiable concentration (AUC0-t) when administered as a single 200 mg oral dose of the test versus reference product
Area under the plasma concentration-time curve from time of intake until the last quantifiable concentration (AUC0-t) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
Secondary outcomes (9)
RDV maximum plasma concentration (tmax) when administered as a single 200 mg oral dose of the test versus reference product
RDV maximum plasma concentration (tmax) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV mean residence time (MRT) when administered as a single 200 mg oral dose of the test versus reference product
RDV mean residence time (MRT) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV elimination rate constant (λz) when administered as a single 200 mg oral dose of the test versus reference product
RDV elimination rate constant (λz) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV elimination half-life (t1/2, estimated based on λz), when administered as a single 200 mg oral dose of the test versus reference product
RDV elimination half-life (t1/2, estimated based on λz) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV apparent volume of distribution when administered as a single 200 mg oral dose of the test versus reference product
RDV apparent volume of distribution will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV terminal phase (Vz/F) when administered as a single 200 mg oral dose of the test versus reference product
RDV terminal phase (Vz/F) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV apparent clearance (CL/F) when administered as a single 200 mg oral dose of the test versus reference product
RDV apparent clearance (CL/F) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
Measured: Measurement within 48 hours post-dose
RDV safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) when administered as a single 200 mg oral dose of the test versus reference product
Safety will be assessed by monitoring clinical adverse events (AEs) incidence
Measured: From 1st patient consent until last patient completes the post-study safety assessment over a total period of 60 days
RDV tolerability (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) when administered as a single 200 mg oral dose of the test versus reference product
Tolerability will be assessed by monitoring clinical adverse events (AEs) incidence
Measured: From 1st patient consent until last patient completes the post-study safety assessment over a total period of 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start5 Jun 2018
- Primary completion17 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damenthi Nair, MD, Principal investigator, KPJ Ampang Puteri Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602300
- Sponsor's protocol ID
- DNDi-RDV-02-HCV
- Status last verified
- Jan 2020
- First submitted
- 21 Jun 2018
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03602300
- Acronym / sponsor ID
- DNDi-RDV-02-HCV
- Conditions
- Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 26 Jul 2018 (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.
In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both Cmax and AUC0-t.
A two-sequence, four-period replicate design will be used to allow the possibility to scale the acceptance range for Cmax if the observed intra-subject coefficient of variation for the reference formulation is greater than 30%
Detailed description
During the course of development, a new batch of ravidasvir tablets has been prepared by the proposed commercial manufacturer (Doppel Farmaceutici, Italy). Tablets manufactured by Doppel Farmaceutici are intended to be used in subsequent clinical trials and be registered as the commercial product. The purpose of this Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study is to assess if ravidasvir 200 mg tablets supplied by European Egyptian Pharmaceutical Industries (EEPI) and tablets from Doppel Farmaceutici are bioequivalent.
Primary objectives:
To compare the rate and extent of absorption for ravidasvir (RDV) when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.
Secondary objectives To evaluate the safety and tolerability of single oral doses of RDV in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study
| Arm | Type | Receives |
|---|---|---|
| Ravidasvir reference formulation | Active comparator | Drug: Ravidasvir reference formulation produced by EEPIRavidasvir 200 mg oral single dose manufactured by EEPI |
| Ravidasvir test formulation | Experimental | Drug: Ravidasvir test formulation produced by DoppelRavidasvir 200 mg oral single dose manufactured by Doppel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- Must be between 18 and 55 years of age, inclusive.
- Must be a non-smoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug. Users of electronic cigarette are not allowed to participate in this study. A smokerlyzer test will be performed to estimate the amount of carbon monoxide in the breath.
- Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
- Must be HIV-1 antibody negative.
Key exclusion criteria (15 listed)
- Healthy volunteers with any hematologic or urinary analyte that is outside the normal limits of the study laboratory and have been determined by the Investigator to have clinical significance at Screening will be excluded
- Pregnant or lactating female healthy volunteers.
- Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
- Have participated in an investigational trial involving administration of any investigational compound within 90 days prior to the study dosing or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial).
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
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 |
|---|---|---|
| Ravidasvir test formulation produced by DoppelTo compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions. | Drug | Ravidasvir test formulation |
| Ravidasvir reference formulation produced by EEPITo compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions. | Drug | Ravidasvir reference formulation |
Primary outcome
RDV Plasma CMax when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
Plasma RDV Cmax will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose
RDV area under the plasma concentration-time curve from time of intake until infinity (AUC0-∞) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
Area under the plasma concentration-time curve from time of intake until infinity (AUC0-∞) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
RDV area under the plasma concentration-time curve from time of intake until the last quantifiable concentration (AUC0-t) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
Area under the plasma concentration-time curve from time of intake until the last quantifiable concentration (AUC0-t) will be calculated based on plasma RDV concentrations at pre-dose (time 0 hours) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, and 48 hours post-dose.
9 secondary outcomes
RDV maximum plasma concentration (tmax) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
RDV mean residence time (MRT) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
RDV elimination rate constant (λz) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
RDV elimination half-life (t1/2, estimated based on λz), when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
RDV apparent volume of distribution when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
RDV terminal phase (Vz/F) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
RDV apparent clearance (CL/F) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: Measurement within 48 hours post-dose
RDV safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: From 1st patient consent until last patient completes the post-study safety assessment over a total period of 60 days
RDV tolerability (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) when administered as a single 200 mg oral dose of the test versus reference product
Time frame: From 1st patient consent until last patient completes the post-study safety assessment over a total period of 60 days
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 31 Jan 2020.
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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.
Damenthi Nair, MD principal investigator
KPJ Ampang Puteri Specialist Hospital
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 Ravidasvir test formulation produced by Doppel and Ravidasvir reference formulation produced by EEPI in people with Bioequivalence Study, run by Drugs for Neglected Diseases at 1 site in Malaysia.
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 14 inclusion and 15 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 31 Jan 2020. 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 Malaysia. 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?
RDV Plasma CMax when administered as a single 200 mg oral dose of the test versus reference product (time frame: Measurement within 48 hours post-dose). The study lists 3 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 31 Jan 2020.