Clinical trial · Interventional
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions
NCT04145570CI-TRIAL-00041360completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween: * ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and * Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib HCl 150 mg | Drug | Erlotinib | ALIAS |
| Tarceva® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib HCl 150 mg
- description
- Crossover
- interventionNames
- Drug: Erlotinib HCl 150 mg
- type
- ACTIVE_COMPARATOR
- label
- Tarceva® 150 mg
- description
- Crossover
- interventionNames
- Drug: Tarceva®
Primary outcomes (1)
- measure
- Bioequivalence (Biodisponibility)
- timeFrame
- 72 hours
- description
- Compared Bioequivalence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects * Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage. Exclusion Criteria: * Known history or presence of any clinically significant medicalcondition. * Known or suspected carcinoma. * Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year. * Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. * Use of tobacco or nicotine-containing products within 6 months priorto drug administration.
References
Publications (0)
Data not yet available
No reference posted for this study.