Clinical trial · Interventional
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions
NCT01367626CI-TRIAL-00031290completedPhase 1ClinicalTrials.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)
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- letrozole
- description
- 2.5 mg tablet
- interventionNames
- Drug: letrozole
- type
- ACTIVE_COMPARATOR
- label
- Fermara
- description
- 2.5 mg tablet
- interventionNames
- Drug: letrozole
Primary outcomes (1)
- measure
- bioequivalence determined by statistical comparison Cmax
- timeFrame
- 31 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: \- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: * Positive test for HIV, Hepatitis B, or Hepatitis C. * Treatment with known enzyme altering drugs. * History of allergic or adverse response to letrozole or any comparable or similar product.
References
Publications (0)
Data not yet available
No reference posted for this study.