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

Tracking Information

• First Submitted Date: May 8, 2012
• First Posted Date: May 10, 2012
• Last Update Posted Date: December 12, 2012
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Bioequivalence Study

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 20, 2012): 71
• Original Estimated Enrollment (submitted: May 9, 2012): 48
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 20 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01595425
• Other Study ID Numbers: D961TC00001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AstraZeneca
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided

Investigators

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

• PRS Account: AstraZeneca
• Verification Date: December 2012