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Completed

NCT Number: NCT01595425

Bioequivalence Study Comparing D961H Sachet and D961H Capsule 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.

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Key information

Conditions

Bioequivalence Study

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Unit

Fukuoka, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Japanese healthy male subjects aged 20 to 45 years of age
  • Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
  • Clinically normal findings
  • Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

Exclusion criteria

  • Significant clinical illness
  • Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
  • Clinical significant condition which could modify the absorption of the investigational product
  • Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention

Treatment and study plan

D961H Sachet 20 mg

Drug

Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.

Other names: esomeprazole sachet

D961H HPMC capsule 20 mg

Drug

Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.

Other names: esomeprazole, capsule 20 mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 10, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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