Influenza, HumanPhase 1NCT01258530
A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers
A Phase 1 study testing over-encapsulated oseltamivir and oseltamivir in people with Influenza, Human, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will be administered in the fasting state. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- over-encapsulated oseltamivir and oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2010to 3 Feb 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.
- Body weight greater than or equal to 50 kg and BMI within the range 18.5 - 31.0 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
- Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy, peptic ulceration, inflammatory bowel disease or pancreatitis should be excluded.
- The subject's systolic blood pressure is outside the range of 90-140 mmHg, or diastolic blood pressure is outside the range of 45-90 mmHg or heart rate is outside the range of 50-100 bpm for female subjects or 45-100 bpm for male subjects.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate Males <45 and >100 bpm Females <50 and >100 bpm; PR Interval <120 and >220 msec; QRS duration <70 and >120 msec; QTc interval (Bazett) >450 msec.
- Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
- Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome, non-sustained or sustained ventricular tachycardia (greater than or equal to 3 consecutive ventricular ectopic beats).sinus pauses > 3 seconds, or other significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety of the individual subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-Dose, Two-Period, Crossover Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers
This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will be administered in the fasting state.
- Conditions
- Influenza, Human
- Being tested
- over-encapsulated oseltamivir, oseltamivir
- Keywords
- influenza, bioequivalence, oseltamivir, Tamiflu, over-encapsulation
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
over-encapsulated oseltamivirDrug
75 mg once
oseltamivirDrug
75 mg once
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Over-encapsulated oseltamivir 75 mg (1 capsule) Receives: Drug: over-encapsulated oseltamivir |
| Treatment B | Experimental | oseltamivir 75 mg (1 capsule) Receives: Drug: oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity))
Measured: 9 days
Plasma oseltamivir carboxylate maximum observed concentration (Cmax)
Measured: 9 days
Secondary outcomes (15)
Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC(0-t))
Measured: 9 days
Plasma oseltamivir carboxylate terminal phase half-life (t1/2)
Measured: 9 days
Plasma oseltamivir carboxylate time of occurrence of Cmax (tmax)
Measured: 9 days
Plasma oseltamivir AUC (0-infinity)
Measured: 9 days
Plasma oseltamivir AUC(0-t)
Measured: 9 days
Plasma oseltamivir Cmax
Measured: 9 days
Plasma oseltamivir t1/2
Measured: 9 days
Plasma oseltamivir lag time before observation of drug concentrations in sampled matrix (tlag)
Measured: 9 days
Plasma oseltamivir tmax
Measured: 9 days
Safety and tolerability of all treatments, including number of subjects with adverse events assessment
Measured: 4 weeks
Safety and tolerability of all treatments, including number of subjects with concurrent medications
Measured: 4 weeks
Safety and tolerability of all treatments, change from baseline and number subjects with abnormal clinical safety laboratory data
Measured: 4 weeks
Safety and tolerability of all treatments, including change from baseline and number of subjects with abnormal ECG assessments
Measured: 4 weeks
Safety and tolerability of all treatments, including change from baseline and number of subjects with abnormal vital signs (blood pressure and heart rate) assessments
Measured: 4 weeks
Plasma oseltamivir carboxylate lag time before observation of drug concentrations in sampled matrix(tlag)
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study start20 Dec 2010
- Primary completion3 Feb 2011
- Study completion3 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258530
- Sponsor's protocol ID
- 115096
- Status last verified
- Jun 2017
- First submitted
- 2 Dec 2010
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-Dose, Two-Period, Crossover Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01258530
- Acronym / sponsor ID
- 115096
- Conditions
- Influenza, Human
- Keywords
- influenza, bioequivalence, oseltamivir, Tamiflu, over-encapsulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2010 (actual)
- Primary completion
- 3 Feb 2011 (actual)
- Study completion
- 3 Feb 2011 (actual)
- First posted
- 13 Dec 2010 (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.
This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will be administered in the fasting state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: over-encapsulated oseltamivirOver-encapsulated oseltamivir 75 mg (1 capsule) |
| Treatment B | Experimental | Drug: oseltamiviroseltamivir 75 mg (1 capsule) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.
- Body weight greater than or equal to 50 kg and BMI within the range 18.5 - 31.0 kg/m2 (inclusive).
Key exclusion criteria (21 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
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 |
|---|---|---|
| over-encapsulated oseltamivir75 mg once | Drug | Treatment A |
| oseltamivir75 mg once | Drug | Treatment B |
Primary outcome
Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity))
Time frame: 9 days
Plasma oseltamivir carboxylate maximum observed concentration (Cmax)
Time frame: 9 days
15 secondary outcomes
Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC(0-t))
Time frame: 9 days
Plasma oseltamivir carboxylate terminal phase half-life (t1/2)
Time frame: 9 days
Plasma oseltamivir carboxylate time of occurrence of Cmax (tmax)
Time frame: 9 days
Plasma oseltamivir AUC (0-infinity)
Time frame: 9 days
Plasma oseltamivir AUC(0-t)
Time frame: 9 days
Plasma oseltamivir Cmax
Time frame: 9 days
Plasma oseltamivir t1/2
Time frame: 9 days
Plasma oseltamivir lag time before observation of drug concentrations in sampled matrix (tlag)
Time frame: 9 days
Plasma oseltamivir tmax
Time frame: 9 days
Safety and tolerability of all treatments, including number of subjects with adverse events assessment
Time frame: 4 weeks
Safety and tolerability of all treatments, including number of subjects with concurrent medications
Time frame: 4 weeks
Safety and tolerability of all treatments, change from baseline and number subjects with abnormal clinical safety laboratory data
Time frame: 4 weeks
Safety and tolerability of all treatments, including change from baseline and number of subjects with abnormal ECG assessments
Time frame: 4 weeks
Safety and tolerability of all treatments, including change from baseline and number of subjects with abnormal vital signs (blood pressure and heart rate) assessments
Time frame: 4 weeks
Plasma oseltamivir carboxylate lag time before observation of drug concentrations in sampled matrix(tlag)
Time frame: 9 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 7 Jun 2017.
- Results for study 115096 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 over-encapsulated oseltamivir and oseltamivir in people with Influenza, Human, run by GlaxoSmithKline at 1 site in United States.
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 6 inclusion and 21 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 7 Jun 2017. 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 United States. 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?
Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)) (time frame: 9 days). 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 7 Jun 2017.