HealthyPhase 1NCT00477126
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
A Phase 1 study testing GPO ritonavir versus Norvir in people with Healthy, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GPO ritonavir versus Norvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2007to Feb 2007
- 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
- Written informed consent
- Healthy male or female 18-45 years old
- Documented negative test for HIV-1 infection < 1 wk prior to start of study and with no risk of
- HIV exposure in the last 6 months
- For female subjects: documented negative pregnancy test <3 wk prior to start of study, not breastfeeding
- BMI 18-25
- Normal physical examination
- Normal CBC, BUN, Cr, AST, ALT, Total bilirubin, no evidence of active or chronic HBV or HCV Infection
Who cannot join
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the study and the procedures required.
- Participation in a drug study within 60 days prior to the first dose.
- Febrile illness within 3 days before the first dose.
- Use of concomitant medication
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- Smoke cigarettes not more than 10 cigarettes a day.
- Drink alcohol not more than 2 units a day
- Discontinue smoking and alcohol for at least 1 month before enrollment.
- Take other medication regularly
- Involvement in any drug addiction
- Heart disease, hypertension, liver disease, kidney disease, GI disease, allergic disease or other diseases which may interfere with the PK of study drugs
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Bangkok, 10330
About this study
Official title: Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
Read the detailed description
This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.
- Conditions
- Healthy
- Being tested
- GPO ritonavir versus Norvir
- Keywords
- ritonavir generic capsule, Norvir®, Thailand, Determine bioequivalence between Norvir and GPO ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPO ritonavir versus NorvirDrug
RTV generic compared to reference drugs (Norvir, Abbott)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | start generic product cross over to reference product Receives: Drug: GPO ritonavir versus Norvir |
| 2 | Active comparator | start reference product cross over to generic product Receives: Drug: GPO ritonavir versus Norvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.
Measured: 2 months
Secondary outcomes (1)
Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- The Government Pharmaceutical Organization
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477126
- Sponsor's protocol ID
- HIV-NAT 037
- Status last verified
- Apr 2012
- First submitted
- 20 May 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00477126
- Acronym / sponsor ID
- HIV-NAT 037
- Conditions
- Healthy
- Keywords
- ritonavir generic capsule, Norvir®, Thailand, Determine bioequivalence between Norvir and GPO ritonavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- The Government Pharmaceutical Organization
- Study start
- Jan 2007
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 22 May 2007 (estimated)
- 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 establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
Detailed description
This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GPO ritonavir versus Norvirstart generic product cross over to reference product |
| 2 | Active comparator | Drug: GPO ritonavir versus Norvirstart reference product cross over to generic product |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Written informed consent
- Healthy male or female 18-45 years old
- Documented negative test for HIV-1 infection < 1 wk prior to start of study and with no risk of
- HIV exposure in the last 6 months
- For female subjects: documented negative pregnancy test <3 wk prior to start of study, not breastfeeding
Key exclusion criteria (12 listed)
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the study and the procedures required.
- Participation in a drug study within 60 days prior to the first dose.
- Febrile illness within 3 days before the first dose.
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 |
|---|---|---|
| GPO ritonavir versus NorvirRTV generic compared to reference drugs (Norvir, Abbott) | Drug | 1, 2 |
Primary outcome
Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.
Time frame: 2 months
1 secondary outcome
Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.
Time frame: 2 months
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 5 Apr 2012.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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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.
Kiat Ruxrungtham, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
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 GPO ritonavir versus Norvir in people with Healthy, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
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 12 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 5 Apr 2012. 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 Thailand. 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?
Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug. (time frame: 2 months). 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 5 Apr 2012.