HealthyPhase 1NCT02253888
Bioequivalence Study of Tipranavir Stored at Controlled Temperature Compared With Tipranavir Stored at Controlled Refrigerated Conditions, Orally Co-administered With Ritonavir in Healthy Male and Female Volunteers
A Phase 1 study testing TPV - Room condition, TPV - Refrigerated conditions and Ritonavir (RTV) in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250 mg SEDDS capsules stored at controlled… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TPV - Room condition, TPV - Refrigerated conditions and Ritonavir (RTV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jun 2005
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females with a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests that have:
- No findings that are abnormal or of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Acceptable laboratory values that indicate adequate baseline organ function at time of screening. Laboratory values are considered acceptable if the severity is less than or equal to Grade 1, according to the AIDS Clinical Trials Group (ACTG) Division of Acquired Immunodeficiency Syndrome (of the National Institute of Allergy and Infectious Diseases / National Institutes of Health) (DAIDS) Grading Scale and within normal reference ranges for other laboratory parameters not defined by DAIDS. Participation of subjects with abnormal laboratory values greater than Grade 1 (e.g., Creatine phosphokinase (CPK), amylase, triglycerides) is subject to approval by the Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) clinical monitor
- Age ≥18 and ≤60 years
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2
Show all 10Show fewer
- Signed and dated written informed consent before admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation concerning volunteers who are capable of understanding and giving informed consent
- Willingness of subjects to abstain from ingesting the following foods and substances beginning 2 weeks before administration of any study medication and until the end of the study: grapefruit or grapefruit juice, red wine, Seville oranges, St. John's Wort and Milk Thistle
- Willingness of subjects to abstain from use of alcohol within 72 hours before administration of study medication and to the end of the study
- Willingness of subjects to abstain from the following substances within 72 hours before administration of study medication: garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.)
Who cannot join
- Chronic gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy, cerebral cramps) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergies or hypersensitivity (including drug allergies) that are deemed relevant to the trial, as judged by the investigator
Show all 30Show fewer
- Intake of drugs with a long half-life (>24 hours) within 1 month or less than 10 half-lives of the drug before administration of study drug or during the trial
- Use of drugs that might reasonably influence the results of the trial (based on knowledge at the time of the protocol's preparation) within 10 days before administration of study drug or during the trial
- Participation in another trial with an investigational drug within 30 days before administration of study drug or during the trial.
- Smoker (more than 10 cigarettes per day, 3 cigars per day or 3 pipes per day)
- Inability to refrain from smoking 24 hours before receiving study medication and on trial days when pharmacokinetic (PK) data are collected
- High level of alcohol use (more than 60 grams per day)
- Illicit drug use (i.e., positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
- Veins unsuited for i.v. puncture on either arm (e.g., veins that are difficult to locate, access or puncture veins with a tendency to rupture during or after puncture)
- Blood donation (more than 100 mL within 4 weeks before administration of study medication or during the trial)
- History of any bleeding disorder or acute blood coagulation defect
- Hypersensitivity to RTV or related antiretroviral drugs
- Extreme physical activities (within 1 week before administration of study medication or during the trial)
- Any laboratory value outside the reference range or >DAIDS Grade 1 that is of clinical relevance
- Heart rate at screening of >90 bpm or <45 bpm
- Seated systolic blood pressure either <95 mm Hg or >160 mm Hg
- Any screening ECG value outside of the reference range of clinical relevance
- Inability to adhere to dietary regimen of the study centre
- For female subjects:
- Pregnancy or planning to become pregnant within 60 days of study completion
- Positive pregnancy test
- Non-use of a barrier method of contraception for at least 3 months before participation in the study
- Not willing or unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
- Breast-feeding
About this study
Official title: An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study Assessing Subjects Receiving Tipranavir 500 mg Stored at Controlled Temperature (Testproduct 30°C/70% RH) Compared With Tipranavir 500 mg Stored at Controlled Refrigerated Conditions (Reference Product 2-8°C), Orally Co-administered With Ritonavir 200 mg Under Fasting Conditions to Healthy Male and Female Volunteers
The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250 mg SEDDS capsules stored at controlled refrigerated conditions between 2°C and 8°C
- Conditions
- Healthy
- Being tested
- TPV - Room condition, TPV - Refrigerated conditions, Ritonavir (RTV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPV - Room conditionDrug
TPV - Refrigerated conditionsDrug
Ritonavir (RTV)Drug
| Study group | Role | What they receive |
|---|---|---|
| TPV/r - Room condition | Experimental | Not described Receives: Drug: TPV - Room condition; Drug: Ritonavir (RTV) |
| TPV/r - Refrigerated conditions | Experimental | Not described Receives: Drug: TPV - Refrigerated conditions; Drug: Ritonavir (RTV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity)
Measured: up to 72 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
Secondary outcomes (10)
AUC0-tz (area under concentration-time curve of the analyte in plasma over the time interval of 0 to time of last quantifiable data point)
Measured: up to 72 hours after drug administration
AUC0-72 (area under concentration-time curve of the analyte in plasma over the time interval t0h to t72h)
Measured: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 72 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz after an extravascular dose)
Measured: up to 72 hours after drug administration
Number of subjects with adverse events
Measured: up to 11 days after last dose of drug administration
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 11 days after last dose of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startMay 2005
- Primary completionJun 2005
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.
- More trials run by Boehringer IngelheimThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253888
- Sponsor's protocol ID
- 1182.93
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study Assessing Subjects Receiving Tipranavir 500 mg Stored at Controlled Temperature (Testproduct 30°C/70% RH) Compared With Tipranavir 500 mg Stored at Controlled Refrigerated Conditions (Reference Product 2-8°C), Orally Co-administered With Ritonavir 200 mg Under Fasting Conditions to Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02253888
- Acronym / sponsor ID
- 1182.93
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2005 (actual)
- First posted
- 1 Oct 2014 (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.
The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250 mg SEDDS capsules stored at controlled refrigerated conditions between 2°C and 8°C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPV/r - Room condition | Experimental | Drug: TPV - Room condition, Drug: Ritonavir (RTV) |
| TPV/r - Refrigerated conditions | Experimental | Drug: TPV - Refrigerated conditions, Drug: Ritonavir (RTV) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy males and females with a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests that have:
- Age ≥18 and ≤60 years
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2
- Signed and dated written informed consent before admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation concerning volunteers who are capable of understanding and giving informed consent
- Willingness of subjects to abstain from ingesting the following foods and substances beginning 2 weeks before administration of any study medication and until the end of the study: grapefruit or grapefruit juice, red wine, Seville oranges, St. John's Wort and Milk Thistle
Key exclusion criteria (30 listed)
- Chronic gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy, cerebral cramps) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 |
|---|---|---|
| TPV - Room condition | Drug | TPV/r - Room condition |
| TPV - Refrigerated conditions | Drug | TPV/r - Refrigerated conditions |
| Ritonavir (RTV) | Drug | TPV/r - Refrigerated conditions, TPV/r - Room condition |
Primary outcome
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity)
Time frame: up to 72 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
10 secondary outcomes
AUC0-tz (area under concentration-time curve of the analyte in plasma over the time interval of 0 to time of last quantifiable data point)
Time frame: up to 72 hours after drug administration
AUC0-72 (area under concentration-time curve of the analyte in plasma over the time interval t0h to t72h)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz after an extravascular dose)
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to 11 days after last dose of drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 11 days after last dose of drug administration
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 1 Oct 2014.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPV - Room condition, TPV - Refrigerated conditions and Ritonavir (RTV) in people with Healthy, run by Boehringer Ingelheim.
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 10 inclusion and 30 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity) (time frame: up to 72 hours after drug administration). 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 1 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.