Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
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ClinicalTrials.gov Identifier: NCT01367626 |
Recruitment Status
:
Completed
First Posted
: June 7, 2011
Last Update Posted
: January 23, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: letrozole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: letrozole
2.5 mg tablet
|
Drug: letrozole
2.5 mg tablet
Other Name: Femara
|
Active Comparator: Fermara
2.5 mg tablet
|
Drug: letrozole
2.5 mg tablet
Other Name: Femara
|
- bioequivalence determined by statistical comparison Cmax [ Time Frame: 31 days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367626
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | Alan K Copa, PharmD | PRAC Institute, Ltd. |
Responsible Party: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT01367626 History of Changes |
Other Study ID Numbers: |
LETR-T25-PVFD-1 |
First Posted: | June 7, 2011 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Additional relevant MeSH terms:
Letrozole Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |