A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product

A Randomized, Two-Way Crossover, Single-Dose Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product (Nexium Powder for Injection and Infusion 40 mg) in Healthy Adult Subjects

To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.

Study Overview

• Status: Unknown
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: Nexium powder for injection and infusion 40 mg; Drug: Esomelone Powder for Solution for Injection / Infusion 40 mg

Detailed Description

This study is designed to assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan. Bioequivalence will be assumed if the 90% confidence interval of the AUC0-t, AUC0-inf and Cmax ratio are within the 80-125% interval for log-transformed values.

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

Contacts and Locations

• Study Contact: Name: Chen Chi Yuan; Phone Number: 886-4-26623020; Email: jackal@bioisred.com

Study Locations

• Taiwan
  • Taichung City, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Yeh Hong Zen, Physician; Phone Number: 886-919085331; Email: yhz@vghtc.gov.tw
    • Sub-Investigator: Chen Chia Chang, Physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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.
3. The normal range of the body mass index should between 18.5 and 25.
4. Normal laboratory determinations results including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, γ-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.
5. Normal hematology results including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.
6. Normal urinalysis results 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, hematopoetic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
5. Planed vaccination during the time course of the study.
6. Participation of any 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 investigator or co-investigator to be undesirable as subjects.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference Drug: Nexium; Name: Nexium powder for injection and infusion 40 mg, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.	Drug: Nexium powder for injection and infusion 40 mg; Reference Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
Active Comparator: Test Drug: Esomelone; Name: Esomelone Powder for Solution for Injection / Infusion 40 mg Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.	Drug: Esomelone Powder for Solution for Injection / Infusion 40 mg; Test Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence will be assumed if the 90% confidence interval of the AUC0-t, AUC0-inf and Cmax ratio are within the 80-125% interval for log-transformed values.	The calculation of the respective pharmacokinetic will be based upon the reported concentrations and sampling times.	Sampling Schedule: 0, 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hr

Collaborators and Investigators

• Sponsor: isRed Pharma & Biotech Research Corporation
• Collaborators: Yung Shin Pharmaceutical Ind. Co., Ltd.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 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