NCT02543606

Brief Summary

Bioequivalence of Two Formulations of Esomeprazole 40mg

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_4 healthy

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

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
Last Updated

September 7, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

August 24, 2015

Last Update Submit

September 4, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The pharmacokinetic parameters of ln transformed data ln(AUC) of the product.

    pre-dose to 12 hours post dose

Study Arms (2)

Esomelone

EXPERIMENTAL

powder for injection/ infusion Esomeprazole 40mg

Drug: EsomeloneDrug: Nexium

Nexium

ACTIVE COMPARATOR

powder for injection/ infusion Esomeprazole 40mg

Drug: EsomeloneDrug: Nexium

Interventions

EsomeloneDRUG

powder for injection/ infusion Esomeprazole 40mg

EsomeloneNexium
NexiumDRUG

powder for injection/ infusion Esomeprazole 40mg

EsomeloneNexium

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult, aged between 20 to 40 years old.
  • Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.
  • no particular clinical significance in clinical examination and laboratory tests within two months (60 days) prior to Period I dosing.
  • normal or considered not clinically significant by the investigator chest X-ray and ECG results within six months (180 days ) prior to Period I dosing.
  • The normal range of the body mass index should be between 18.5 and 25; body mass index equals \[weight (kg)\]/\[height (m)\]2.
  • Normal laboratory determinations result (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.
  • Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.
  • Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.
  • Female subject who is
  • using adequate contraception since last menstruation and no plan for conception during the study,
  • non-lactating.
  • has negative pregnancy test (urine) within 14 days prior to the study.
  • Informed consent form signed.

You may not qualify if:

  • A history of drug or alcohol abuse during the past 24 weeks.
  • Sensitivity to analogous drug.
  • A clinically significant illness (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, melaena or gastric ulcer) within the past 4 weeks.
  • Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
  • Planned vaccination during the time course of the study.
  • Participation of ant clinical investigation during the last 60 days.
  • Regular use of any medication during the last 4 weeks.
  • Single use of any medication during the last 2 weeks.
  • Blood donation of more than 250 mL within the past 12 weeks.
  • Individuals are judged by the investigation or co-investigator to be undesirable as subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Hong-Zen Yeh, M.D.

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

September 7, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-07

Locations

TW(1)