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

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

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date December 12, 2012
Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • 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
  • 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. ]
  • Number of participants with adverse events. [ Time Frame: Up to 5 to 7 days after the last dose. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Bioequivalence Study
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: D961H Sachet 20 mg
    2 way crossover
    Intervention: Drug: D961H Sachet 20 mg
  • Experimental: D961HHPMC Capsule 20 mg
    2 way crossover
    Intervention: Drug: D961H HPMC capsule 20 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2012)
71
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2012)
48
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595425
Other Study ID Numbers  ICMJE D961TC00001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Masataka Date AstraZeneca R&D Japan
Principal Investigator: Masanari Shiramoto Hakata Clinic
PRS Account AstraZeneca
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP