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Status unknownNCT03120273Updated Apr 19, 2017

A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）

A Phase 1 interventional study of Dexlansoprazole Injection and Lansoprazole Injection in Effect of Drugs and Safety Issues, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-19.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of an investigational dexlansoprazole injection after multiple intravenous administration in healthy Chinese adults.

Read the detailed description

This is a single center, open-label, multiple-dose clinical trial. 5 dosing groups were designed, including 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days, and 30 mg q12h in an active comparator, lansoprazole, treatment arm for 5 days. The study will enroll approximately 70 participants with 14 cases in each group. Participants will make 3 visits to the clinic including 8-day of confinement to the clinic.

02

Conditions studied

  • Effect of Drugs
  • Safety Issues
03

In context

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age ≥18 Years;
  • Male (weight ≥50kg) or female (weight ≥45kg);
  • Body mass index (BMI) between 19\~28 kg/m2;
  • In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;
  • Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress;
  • Female participant of childbearing potential must have a negative serum pregnancy test at screening, and agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 6 months following the last dose of study drug;
  • Male participant agrees to use adequate contraception and have no plan to donate sperm from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

Exclusion criteria

Exclusion Criteria:

  • Positive breath test result for H pylori at Screening;
  • Cannot tolerate placement of the pH probe;
  • Has poor peripheral venous access;
  • Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
  • Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
  • Human immunodeficiency virus(HIV), hepatitis B virus(HBV), or syphilis positive;
  • Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months preceding this study or is unwilling to agree to abstain from alcohol and drugs throughout the study;
  • Heavy smokers (>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;
  • Participation in another study with an investigational drug within the last 3 months preceding this study;
  • Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;
  • Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Dexlansoprazole Injection

    15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days

    Drug: Dexlansoprazole Injection

  • Active comparator
    Lansoprazole Injection

    30 mg q12h in lansoprazole treatment arm for 5 days.

    Drug: Lansoprazole Injection

Interventions

  • DrugDexlansoprazole Injection

    15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days

  • DrugLansoprazole Injection

    30 mg q12h for 5 days.

06

What researchers measure

Primary outcomes

  1. Percentage time with the intragastric potential of hydrogen (pH)>4

    Duration of intragastric pH\>4 within 24 hours postdose

    Time frame: 24 hours post-dose on Day 5

  2. Percentage time with the intragastric pH>6

    Duration of intragastric pH\>6 within 24 hours postdose

    Time frame: 24 hours post-dose on Day 5

  3. The time of the intragastric pH reaching 4

    The time of intragastric pH reaching 4 after the last dose

    Time frame: 12 hours post-dose on Day 5

  4. The time of the intragastric pH reaching 6

    The time of intragastric pH reaching 6 after the last dose

    Time frame: 12 hours post-dose on Day 5

Secondary outcomes

  1. Mean intragastric pH

    Mean intragastric pH

    Time frame: 24 hours post-dose on Day 5

  2. Mean intragastric pH per hour

    Mean intragastric pH per hour

    Time frame: 24 hours post-dose on Day 5

  3. Percentage time with the intragastric pH>4 during the first 4 hours

    Duration of intragastric pH\>4 within first 4 hours postdose

    Time frame: 4 hours post-dose on Day 5

  4. Percentage time with the intragastric pH>6 during the first 4 hours

    Duration of intragastric pH\>6 within first 4 hours postdose

    Time frame: 4 hours post-dose on Day 5

  5. Percentage of the participants with duration time of intragastric pH>4 over 12h

    Numbers of participants with duration time of intragastric pH\>4 over 12h

    Time frame: 12 hours post-dose on Day 5

  6. Percentage of the participants with duration time of intragastric pH>6 over 12h

    Numbers of participants with duration time of intragastric pH\>6 over 12h

    Time frame: 12 hours post-dose on Day 5

  7. Cmax on day 1

    Maximum observed plasma concentration for dexlansoprazole

    Time frame: 12 hours post-dose on Day 5

  8. Cmax on day 5

    Maximum observed plasma concentration for dexlansoprazole

    Time frame: 12 hours post-dose on Day 5

  9. Area under the plasma concentration-time curve (AUC) on day 1

    AUC from time 0 to the time of the last quantifiable concentration on day 1

    Time frame: 12 hours post-dose on Day 5

  10. AUC(0-12h) on day 5

    AUC from time 0 to the time of the last quantifiable concentration on day 5

    Time frame: 12 hours post-dose on Day 5

  11. AUC(0-inf) on day 1

    AUC from time 0 to extrapolated to infinity on day 1

    Time frame: 12 hours post-dose on Day 5

  12. AUC(0-inf) on day 5

    AUC from time 0 to extrapolated to infinity on day 5

    Time frame: 12 hours post-dose on Day 5

07

Study locations

1 of 1 sites recruiting
  • First affiliated hospital of Zhejiang University
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

References and documents

Publications

  • Wu L, Liu J, Zheng Y, Zhai Y, Lin M, Wu G, Lv D, Shentu J. Pharmacokinetic/Pharmacodynamic Evaluation of Dexlansoprazole Infusion Injection Compared with Lansoprazole in Healthy Chinese Adults. Clin Drug Investig. 2019 Oct;39(10):953-965. doi: 10.1007/s40261-019-00824-2. PubMed 31338800 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03120273
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 19, 2017
Start date
May 5, 2017 (estimated)
Primary completion
Aug 31, 2017 (estimated)
Completion
Sep 30, 2017 (estimated)
Last update
Apr 19, 2017

Study contacts

Lihua Wu, Doctor
Contact
lihuawu73@163.com
86-13819195192
Lihua Wu, Doctor
principal investigator · Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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