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

• ClinicalTrials.gov Identifier: NCT01595425
• Recruitment Status: Completed
• First Posted: May 10, 2012
• Last Update Posted: December 12, 2012
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bioequivalence Study	Drug: D961H Sachet 20 mg; Drug: D961H HPMC capsule 20 mg	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. AUCτ and Cmax,ss of D961H [ Time Frame: Day 5 ]
   • 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

Secondary Outcome Measures :

1. Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2. [ Time Frame: Day 5 ]
   • 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
2. Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature. [ Time Frame: Up to 5 to 7 days after the last dose. ]
3. Number of participants with adverse events. [ Time Frame: Up to 5 to 7 days after the last dose. ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Japan

Research Unit

Fukuoka-shi, Fukuoka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01595425
• Other Study ID Numbers: D961TC00001
• First Posted: May 10, 2012
• Last Update Posted: December 12, 2012
• Last Verified: December 2012

Keywords provided by AstraZeneca:

Bioequivalence,; pharmacokinetics,; safety,; esomeprazole,; Japanese,; healthy subject,; homo-EM

Additional relevant MeSH terms:

Esomeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action