Bioequivalence of Two Formulations of Esomeprazole

Study Overview
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Brief Summary
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Bioequivalence of Two Formulations of Esomeprazole 40mg

Detailed Description
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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.

Official Title
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A Randomized, Two-way Crossover, Single-dose Pharmacokinetic Study to Evaluate the Bioequivalence of Esomelone for Injection/Infusion (Esomeprazole 40mg), Compared to Reference Drug (Nexium 40mg) in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Esomelone
* Drug: Nexium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomelone<br>powder for injection/ infusion Esomeprazole 40mg | Drug: Esomelone<br>* powder for injection/ infusion Esomeprazole 40mg<br>Drug: Nexium<br>* powder for injection/ infusion Esomeprazole 40mg<br>|
| Active Comparator: Nexium<br>powder for injection/ infusion Esomeprazole 40mg | Drug: Esomelone<br>* powder for injection/ infusion Esomeprazole 40mg<br>Drug: Nexium<br>* powder for injection/ infusion Esomeprazole 40mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic parameters of ln transformed data ln(AUC) of the product. |  | pre-dose to 12 hours post dose |