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

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

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence Study
• Intervention / Treatment: Drug: D961H Sachet 20 mg; Drug: D961H HPMC capsule 20 mg

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

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan
      • Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specific procedures
2. Japanese healthy male subjects aged 20 to 45 years of age
3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
4. Clinically normal findings
5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

Exclusion Criteria:

1. Significant clinical illness
2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
3. Clinical significant condition which could modify the absorption of the investigational product
4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Masataka Date, AstraZeneca R&D Japan; Principal Investigator: Masanari Shiramoto, Hakata Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: safety,; pharmacokinetics,; Japanese,; Bioequivalence,; esomeprazole,; healthy subject,; homo-EM
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D961TC00001