Bioequivalence of Two Formulations of Esomeprazole

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Esomelone; Drug: Nexium

• Registration Number: NCT02543606
• Lead Sponsor: Yung Shin Pharm. Ind. Co., Ltd.

Brief Summary

Bioequivalence of Two Formulations of Esomeprazole 40mg

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 Timeline

• Study Start: 2015-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-09-04
• Last Update Submitted: 2015-09-04
• Study First Posted: 2015-09-07
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Esomelone	Esomelone	powder for injection/ infusion Esomeprazole 40mg
Esomelone	Nexium	powder for injection/ infusion Esomeprazole 40mg
Nexium	Esomelone	powder for injection/ infusion Esomeprazole 40mg
Nexium	Nexium	powder for injection/ infusion Esomeprazole 40mg

Primary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan