Bioequivalence of Two Formulations of Esomeprazole

A randomized, two-way crossover, single-dose pharmacokinetic study to evaluate the bioequivalence of a test formulation of Esomelone powder for solution for injection/infusion 40mg (Esomeprazole 40mg), compared to an equivalent dose of a reference drug product (Nexium powder for injection and infusion 40mg) in healthy adult subjects.

Inclusion criteria

• Healthy adult, aged between 20 to 40 years old.
• Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.

• no particular clinical significance in clinical examination and laboratory tests within two months (60 days) prior to Period I dosing.
• normal or considered not clinically significant by the investigator chest X-ray and ECG results within six months (180 days ) prior to Period I dosing.
• The normal range of the body mass index should be between 18.5 and 25; body mass index equals [weight (kg)]/[height (m)]2.
• Normal laboratory determinations result (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.
• Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.
• Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.
• Female subject who is

• using adequate contraception since last menstruation and no plan for conception during the study,
• non-lactating.
• has negative pregnancy test (urine) within 14 days prior to the study.
• Informed consent form signed.

Exclusion criteria

• A history of drug or alcohol abuse during the past 24 weeks.
• Sensitivity to analogous drug.
• A clinically significant illness (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, melaena or gastric ulcer) within the past 4 weeks.
• Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
• Planned vaccination during the time course of the study.
• Participation of ant clinical investigation during the last 60 days.
• Regular use of any medication during the last 4 weeks.
• Single use of any medication during the last 2 weeks.
• Blood donation of more than 250 mL within the past 12 weeks.
• Individuals are judged by the investigation or co-investigator to be undesirable as subjects.