Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mg
Summary
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 administration under fasting conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Pioglitazone HCl Tablets 45 mg, Actos® Tablets 45 mg
Location
PRACS Institute, Ltd.
Fargo
North Dakota
United States
58104
Status
Completed
Source
Mylan Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00649558
- 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
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...
Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus
This study is being done to determine if pioglitazone (Actos) is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabe...
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2...
Food 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...
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...
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