Healthy VolunteerPhase 1NCT03214159
Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects
A Phase 1 study testing Ritonavir Tablet 100mg and NORVIR tablet 100mg in people with Healthy Volunteer, run by First Affiliated Hospital of Zhejiang University at 2 sites 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 condition. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Ritonavir Tablet 100mg and NORVIR tablet 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 11 Jul 2017to 20 Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers of 18-45 years old.
- Male (weight ≥50kg)
- 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;
- 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;
- 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;
Show all 16Show fewer
- 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
2 sites in 1 country.
China2 sites
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
First affiliated hospital of Zhejiang University
Hanzhou, Zhejiang, 310003
About this study
Official title: An Open-label, Randomized Bioequivalence Study (Preliminary 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 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 condition.
- Conditions
- Healthy Volunteer
- Being tested
- Ritonavir Tablet 100mg, NORVIR tablet 100mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritonavir Tablet 100mgDrug
Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.
NORVIR tablet 100mgDrug
NORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition.
Intervention:
cylcle 1 Drug: Ritonavir tablet 100mg cylcle 2 Drug: NORVIR tablet 100mg cylcle 3 Drug: Ritonavir tablet 100mg cylcle 4 Drug: NORVIR tablet 100mg Receives: Drug: Ritonavir Tablet 100mg; Drug: NORVIR tablet 100mg |
| group 2 | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition.
Intervention:
cylcle 1 Drug: NORVIR tablet 100mg cylcle 2 Drug: Ritonavir tablet 100mg cylcle 3 Drug: NORVIR tablet 100mg cylcle 4 Drug: Ritonavir tablet 100mg Receives: Drug: Ritonavir Tablet 100mg; Drug: NORVIR tablet 100mg |
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 1,7,13 and 19
Tmax
Time to Reach the Maximum Plasma Concentration
Measured: 36 hours post-dose on Day 1,7,13 and 19
AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity
Measured: Time Frame: 36 hours post-dose on Day 1,7,13 and 19
AUC(0-36h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
AUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose.
Measured: 36 hours post-dose on Day 1,7,13 and 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start11 Jul 2017
- Primary completion31 Aug 2017
- Study completion20 Sep 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ascletis Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214159
- Sponsor's protocol ID
- ZYYY-LTNW-BE-2017-05
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT03214159
- Acronym / sponsor ID
- ZYYY-LTNW-BE-2017-05
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ascletis Pharmaceutical Co., Ltd.
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 11 Jul 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 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 condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Ritonavir Tablet 100mg, Drug: NORVIR tablet 100mgDuring the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: Ritonavir tablet 100mg cylcle 2 Drug: NORVIR tablet 100mg cylcle 3 Drug: Ritonavir tablet 100mg cylcle 4 Drug: NORVIR tablet 100mg |
| group 2 | Experimental | Drug: Ritonavir Tablet 100mg, Drug: NORVIR tablet 100mgDuring the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: NORVIR tablet 100mg cylcle 2 Drug: Ritonavir tablet 100mg cylcle 3 Drug: NORVIR tablet 100mg cylcle 4 Drug: Ritonavir tablet 100mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult volunteers of 18-45 years old.
- Male (weight ≥50kg)
- 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;
- 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;
Key exclusion criteria (16 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 Tablet 100mgRitonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd. | Drug | group 1, group 2 |
| NORVIR tablet 100mgNORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study. | Drug | group 1, group 2 |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for ritonavir
Time frame: 36 hours post-dose on Day 1,7,13 and 19
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 1,7,13 and 19
Time to Reach the Maximum Plasma Concentration
AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
Time frame: Time Frame: 36 hours post-dose on Day 1,7,13 and 19
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity
AUC(0-36h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
Time frame: 36 hours post-dose on Day 1,7,13 and 19
AUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose.
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 3 Oct 2017.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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.
2 sites 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 Tablet 100mg and NORVIR tablet 100mg in people with Healthy Volunteer, run by First Affiliated Hospital of Zhejiang University at 2 sites 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 7 inclusion and 16 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 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Maximum Observed Plasma Concentration for ritonavir (time frame: 36 hours post-dose on Day 1,7,13 and 19). 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 3 Oct 2017.