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

Healthy Adult Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444507
• Other study ID #: YSP RFH3002-01
• Status: Recruiting
• Phase: Phase 4
• First received: May 8, 2015
• Last updated: May 11, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: isRed Pharma & Biotech Research Corporation
• Contact: Chen Chi Yuan
• Phone: 886-4-26623020
• Email: jackal[@]bioisred.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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, ?-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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung City

Sponsors (2)

Lead Sponsor	Collaborator
isRed Pharma & Biotech Research Corporation	Yung Shin Pharmaceutical Ind. Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No