Bioequivalence of Two Formulations of Esomeprazole

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

Bioequivalence of Two Formulations of Esomeprazole 40mg

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Esomelone; Drug: Nexium

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult, aged between 20 to 40 years old.

2. 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.
3. The normal range of the body mass index should be between 18.5 and 25; body mass index equals [weight (kg)]/[height (m)]2.
4. 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.
5. 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.
6. Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.

7. 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.
8. Informed consent form signed.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esomelone; powder for injection/ infusion Esomeprazole 40mg	Drug: Esomelone; powder for injection/ infusion Esomeprazole 40mg; Drug: Nexium; powder for injection/ infusion Esomeprazole 40mg
Active Comparator: Nexium; powder for injection/ infusion Esomeprazole 40mg	Drug: Esomelone; powder for injection/ infusion Esomeprazole 40mg; Drug: Nexium; powder for injection/ infusion Esomeprazole 40mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yung Shin Pharm. Ind. Co., Ltd.
• Collaborators: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Hong-Zen Yeh, M.D., Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: YSP-RFH3002-01