Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

Detailed Description
-----------------
A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Official Title
-----------------
A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Conditions
-----------------
Bioequivalence Study

Intervention / Treatment
-----------------
* Drug: D961H Sachet 20 mg
* Drug: D961H HPMC capsule 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Japanese healthy male subjects aged 20 to 45 years of age Body Mass Index 19-27 kg/m2 and body weight 50-85 kg Clinically normal findings Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19 Exclusion Criteria: Significant clinical illness Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease Clinical significant condition which could modify the absorption of the investigational product Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D961H Sachet 20 mg<br>2 way crossover | Drug: D961H Sachet 20 mg<br>* Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.<br>* Other names: esomeprazole sachet;|
| Experimental: D961HHPMC Capsule 20 mg<br>2 way crossover | Drug: D961H HPMC capsule 20 mg<br>* Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.<br>* Other names: capsule 20 mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ and Cmax,ss of D961H | AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration Cmax,ss - maximum concentration at steady state | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2. | AUC0-t,ss-Area under plasma concentration time curve from zero to time of the last measurable concentration at steady state MRT- Mean residence time tmax,ss -time of maximum concentration at steady state t½ -Terminal half-life | Day 5 | 
| Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature. |  | Up to 5 to 7 days after the last dose. | 
| Number of participants with adverse events. |  | Up to 5 to 7 days after the last dose. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence,, pharmacokinetics,, safety,, esomeprazole,, Japanese,, healthy subject,, homo-EM