NCT01494402

Brief Summary

The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

December 15, 2011

Last Update Submit

April 6, 2012

Conditions

Bioequivalence Study

Keywords

Healthy volunteer, Japanese males, homo-EM

Outcome Measures

Primary Outcomes (2)

  • Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).

    All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.

    Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6

  • Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)

    All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.

    Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6

Secondary Outcomes (2)

  • Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA

    Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6

  • Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.

    Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)

Study Arms (2)

D961S

EXPERIMENTAL

2 way crossover

Drug: D961S

esomeprazole + buffered acetylsalicylic acid

EXPERIMENTAL

2 way crossover

Drug: EsomeprazoleDrug: Buffered acetylsalicylic acid

Interventions

D961SDRUG

Oral gelatine capsule

D961S
EsomeprazoleDRUG

Oral HPMC capsule

Also known as: Nexium® capsule 20 mg
esomeprazole + buffered acetylsalicylic acid
Buffered acetylsalicylic acidDRUG

Tablet

Also known as: Bufferin Combination Tablet A81
esomeprazole + buffered acetylsalicylic acid

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese males 20-45 years of age
  • Classified as homo-EM
  • Negative for HIV, Hepatitis B, Hepatitis C and syphilis
  • Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
  • Body weight 50-85 kg

You may not qualify if:

  • Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
  • Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
  • Need for concomitant medication in the study
  • Past or present NSAIDs induced asthma
  • History of bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study site

Hakata, Fukuoka, Japan

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 19, 2011

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations

JP(1)