Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01595425
First received: May 8, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Bioequivalence Study
 Drug: D961H Sachet 20 mg
Drug: D961H HPMC capsule 20 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • AUCτ and Cmax,ss of D961H [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    • 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:
  • Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    • 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

  • 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. ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events. [ Time Frame: Up to 5 to 7 days after the last dose. ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595425

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01595425     History of Changes
Other Study ID Numbers: D961TC00001
Study First Received: May 8, 2012
Last Updated: December 11, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Bioequivalence,
pharmacokinetics,
safety,
esomeprazole,
 Japanese,
healthy subject,
homo-EM

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013