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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01595425

Enrollment

Registered

2012-05-10

Start date

2012-05-31

Completion date

2012-06-30

Last updated

2012-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence Study

Keywords

Bioequivalence,, pharmacokinetics,, safety,, esomeprazole,, Japanese,, healthy subject,, homo-EM

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

Interventions

DRUGD961H Sachet 20 mg

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

DRUGD961H HPMC capsule 20 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUCτ and Cmax,ss of D961H	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

Measure	Time frame	Description
Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.	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.	Up to 5 to 7 days after the last dose.	—
Number of participants with adverse events.	Up to 5 to 7 days after the last dose.	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026