Bioequivalence of Two Formulations of Esomeprazole

Yung Shin Pharm

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Nexium; Drug: Esomelone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02543606

YSP-RFH3002-01

Details and patient eligibility

About

Bioequivalence of Two Formulations of Esomeprazole 40mg

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Esomelone

Experimental group

Description:

powder for injection/ infusion Esomeprazole 40mg

Treatment:

Drug: Nexium

Drug: Esomelone

Nexium

Active Comparator group

Description:

powder for injection/ infusion Esomeprazole 40mg

Treatment:

Drug: Nexium

Drug: Esomelone