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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Over-encapsulated oseltamivir 75 mg (1 capsule) |
|
| Treatment B | Experimental | oseltamivir 75 mg (1 capsule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| over-encapsulated oseltamivir | Drug | 75 mg once |
| |
| oseltamivir |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)) | 9 days | |
| Plasma oseltamivir carboxylate maximum observed concentration (Cmax) | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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)) | 9 days | |
| Plasma oseltamivir carboxylate terminal phase half-life (t1/2) | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
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| Label | URL |
|---|---|
| Results for study 115096 can be found on the GSK Clinical Study Register. | View source |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115096 | Clinical Study Report | View IPD |
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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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Drug |
75 mg once |
|
| Plasma oseltamivir carboxylate time of occurrence of Cmax (tmax) | 9 days |
| Plasma oseltamivir AUC (0-infinity) | 9 days |
| Plasma oseltamivir AUC(0-t) | 9 days |
| Plasma oseltamivir Cmax | 9 days |
| Plasma oseltamivir t1/2 | 9 days |
| Plasma oseltamivir lag time before observation of drug concentrations in sampled matrix (tlag) | 9 days |
| Plasma oseltamivir tmax | 9 days |
| Safety and tolerability of all treatments, including number of subjects with adverse events assessment | 4 weeks |
| Safety and tolerability of all treatments, including number of subjects with concurrent medications | 4 weeks |
| Safety and tolerability of all treatments, change from baseline and number subjects with abnormal clinical safety laboratory data | 4 weeks |
| Safety and tolerability of all treatments, including change from baseline and number of subjects with abnormal ECG assessments | 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 | 4 weeks |
| Plasma oseltamivir carboxylate lag time before observation of drug concentrations in sampled matrix(tlag) | 9 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115096 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115096 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115096 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115096 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115096 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115096 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |