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

May 8, 2012
December 11, 2012
May 2012
June 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01595425 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Bioequivalence Study
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01595425
D961TC00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Masataka Date AstraZeneca R&D Japan
Principal Investigator: Masanari Shiramoto Hakata Clinic
AstraZeneca
December 2012

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