Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
Summary
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fed conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Letrozole Tablets 2.5 mg, Femara® Tablets 2.5 mg
Location
SFBC International
Miami
Florida
United States
33181
Status
Completed
Source
Mylan Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00648154
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Lactose
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
Tablets
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Excipients
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
Talc
Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)
Clinical Trials
Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose...
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrom...
Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Breast Cancer Patients
The goal of this clinical research study is to learn if the combination of Femara (letrozole) and Gleevec (imatinib mesylate) can shrink or slow the growth of the tumor in patients who hav...
Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mg
The objective of this study was to investigate the bioequivalence of Mylan pioglitazone HCl 45 mg tablets to Takeda Actos® 45 mg tablets following a single, oral 45 mg (1 x 45 mg) dose ad...
Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg
The objective of this study was to investigate the bioequivalence of Mylan's glimepiride 1 mg tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose adminis...
PubMed Articles
The purpose of this study was to compare the in vitro release and the in vivo pharmacokinetics of bilayer tablets with the conventional dispersible tablets of nimesulide. The tablets were administered...
Dissolution profile of 24 levofloxacin (100 mg) tablets.
Although there are 23 generic levofloxacin (100 mg) tablets (LVFX tablets) and 1 brand name LVFX tablet (supply now discontinued) in Japan, there have been no reports that have evaluated and compared...
Famotidine is generally employed for the treatment of gastric ulcer. The present study was conducted to fabricate famotidine tablets using various diluents. The binder was incorporated to the formulat...
The wet granulation method was successfully used to manufacture amorphous telmisartan tablets (CNU) for comparison with the spray-drying method, used for Pritor™. Drug crystallinity in the tablet wa...
Meta-chlorophenylpiperazine (m-CPP) is a new illicit drug that has been sold as ecstasy tablets. Easy ambient sonic-spray ionization mass spectrometry (EASI-MS) and X-ray fluorescence spectrometry (XR...
