Healthy VolunteerPhase 1RTVNCT03302182
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
A Phase 1 study testing Ritonavir for cycle1 and NORVIR for cycle 2 and NORVIR for cycle 1 and Ritonavir for cycle 2 in people with Healthy Volunteer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Ritonavir for cycle1 and NORVIR for cycle 2 and NORVIR for cycle 1 and Ritonavir for cycle 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2017to 4 Dec 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers of 18-45 years old.
- Male (weight ≥50kg);Female (weight ≥45kg)
- Body mass index (BMI) between 19~28 kg/m2;
- In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;
- Female participant with negative result of HCG test and agrees to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Male participant agrees to use adequate contraception and have no plan to donate sperm from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress;
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
Who cannot join
- Subject who cannot tolerate venipuncture.
- Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- Abnormal results of physical examination (hematology, urine test,blood biochemistry etc.), vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) or x-ray with clinical significance.
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test;
- Women who is during lactation, pregnancy or plan to have baby recently.
Show all 18Show fewer
- Women with positive result of HCG test.
- Subject who refuse to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months preceding this study or is unwilling to agree to abstain from alcohol and drugs throughout the study;
- Heavy smokers (>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;
- Positive test results for alcohol or drug at Screening;
- History of hospitalization or surgery within 3 months preceding this study.
- Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;
- Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
- Participation in another study with an investigational drug within the last 3 months preceding this study;
- History of gastrointestinal surgery, vagotomy, enterotomy or other surgery that may influence gastrointestinal motility,PH or gastrointestinal absorption.
- Intake of grapefruit or orange (or other food containing grapefruit or orange) 3 days previous to the start of the study. Intake of tea,coffee or other drink containing coffee more than 1L per day.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive Ritonavir.
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: An Open-label, Randomized Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition.
Read the detailed description
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 6 days. During each session, the subjects will be administered a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg) under fasting or fed condition.
- Conditions
- Healthy Volunteer
- Being tested
- Ritonavir for cycle1 and NORVIR for cycle 2, NORVIR for cycle 1 and Ritonavir for cycle 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritonavir for cycle1 and NORVIR for cycle 2Drug
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .
NORVIR for cycle 1 and Ritonavir for cycle 2Drug
During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .
| Study group | Role | What they receive |
|---|---|---|
| fasting group | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition.
For group1:
cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg
For group2:
cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg Receives: Drug: Ritonavir for cycle1 and NORVIR for cycle 2; Drug: NORVIR for cycle 1 and Ritonavir for cycle 2 |
| Fed group | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition.
For group3:
cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg
For group4:
cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg Receives: Drug: Ritonavir for cycle1 and NORVIR for cycle 2; Drug: NORVIR for cycle 1 and Ritonavir for cycle 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Plasma Concentration for ritonavir
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: 36 hours post-dose on Day 1,7
Tmax
Time to Reach the Maximum Plasma Concentration
Measured: 36 hours post-dose on Day 1,7
AUC(0-inf)
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
Measured: Time Frame: 36 hours post-dose on Day 1,7
AUC(0-36h)
Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
Measured: 36 hours post-dose on Day 1,7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start23 Sep 2017
- Primary completion4 Nov 2017
- Study completion4 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302182
- Sponsor's protocol ID
- ZYYY-LTNW-BE-2017-05-2
- Acronym
- RTV
- Status last verified
- Sep 2017
- First submitted
- 30 Sep 2017
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT03302182
- Acronym / sponsor ID
- RTV / ZYYY-LTNW-BE-2017-05-2
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
- Study start
- 23 Sep 2017 (actual)
- Primary completion
- 4 Nov 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 5 Oct 2017 (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.
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition.
Detailed description
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 6 days. During each session, the subjects will be administered a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg) under fasting or fed condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fasting group | Experimental | Drug: Ritonavir for cycle1 and NORVIR for cycle 2, Drug: NORVIR for cycle 1 and Ritonavir for cycle 2During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition. For group1: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group2: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg |
| Fed group | Experimental | Drug: Ritonavir for cycle1 and NORVIR for cycle 2, Drug: NORVIR for cycle 1 and Ritonavir for cycle 2During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition. For group3: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group4: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult volunteers of 18-45 years old.
- Male (weight ≥50kg);Female (weight ≥45kg)
- Body mass index (BMI) between 19~28 kg/m2;
- In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;
- Female participant with negative result of HCG test and agrees to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
Key exclusion criteria (18 listed)
- Subject who cannot tolerate venipuncture.
- Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- Abnormal results of physical examination (hematology, urine test,blood biochemistry etc.), vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) or x-ray with clinical significance.
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test;
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 |
|---|---|---|
| Ritonavir for cycle1 and NORVIR for cycle 2During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 . | Drug | Fed group, fasting group |
| NORVIR for cycle 1 and Ritonavir for cycle 2During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 . | Drug | Fed group, fasting group |
Primary outcome
Cmax
Time frame: 36 hours post-dose on Day 1,7
Maximum Observed Plasma Concentration for ritonavir Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Tmax
Time frame: 36 hours post-dose on Day 1,7
Time to Reach the Maximum Plasma Concentration
AUC(0-inf)
Time frame: Time Frame: 36 hours post-dose on Day 1,7
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
AUC(0-36h)
Time frame: 36 hours post-dose on Day 1,7
Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
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 21 Mar 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ritonavir for cycle1 and NORVIR for cycle 2 and NORVIR for cycle 1 and Ritonavir for cycle 2 in people with Healthy Volunteer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 8 inclusion and 18 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 21 Mar 2018. 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 China. 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?
Cmax (time frame: 36 hours post-dose on Day 1,7). The study lists 4 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 21 Mar 2018.