Effect of DrugsPhase 1NCT03120273
A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）
A Phase 1 study testing Dexlansoprazole Injection and Lansoprazole Injection in people with Effect of Drugs and Safety Issues, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effect of Drugs, Safety Issues
- What is being tested?
- Dexlansoprazole Injection and Lansoprazole Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2017to 30 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Lihua Wu, Doctor, 86 571 87236560, lihuawu73@163.com
Jian Liu, Master, 86 571 87236560, lindaliu87@163.com
About this study
Official title: A Phase 1 Clinical Trial to Evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety in Healthy Chinese Adults After Multiple Intravenous Administration of Dexlansoprazole
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.
- Conditions
- Effect of Drugs, Safety Issues
- Being tested
- Dexlansoprazole Injection, Lansoprazole Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexlansoprazole InjectionDrug
15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days
Lansoprazole InjectionDrug
30 mg q12h for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Dexlansoprazole Injection | Experimental | 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days Receives: Drug: Dexlansoprazole Injection |
| Lansoprazole Injection | Active comparator | 30 mg q12h in lansoprazole treatment arm for 5 days. Receives: Drug: Lansoprazole Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage time with the intragastric potential of hydrogen (pH)>4
Duration of intragastric pH>4 within 24 hours postdose
Measured: 24 hours post-dose on Day 5
Percentage time with the intragastric pH>6
Duration of intragastric pH>6 within 24 hours postdose
Measured: 24 hours post-dose on Day 5
The time of the intragastric pH reaching 4
The time of intragastric pH reaching 4 after the last dose
Measured: 12 hours post-dose on Day 5
The time of the intragastric pH reaching 6
The time of intragastric pH reaching 6 after the last dose
Measured: 12 hours post-dose on Day 5
Secondary outcomes (12)
Mean intragastric pH
Mean intragastric pH
Measured: 24 hours post-dose on Day 5
Mean intragastric pH per hour
Mean intragastric pH per hour
Measured: 24 hours post-dose on Day 5
Percentage time with the intragastric pH>4 during the first 4 hours
Duration of intragastric pH>4 within first 4 hours postdose
Measured: 4 hours post-dose on Day 5
Percentage time with the intragastric pH>6 during the first 4 hours
Duration of intragastric pH>6 within first 4 hours postdose
Measured: 4 hours post-dose on Day 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
Measured: 12 hours post-dose on Day 5
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
Measured: 12 hours post-dose on Day 5
Cmax on day 1
Maximum observed plasma concentration for dexlansoprazole
Measured: 12 hours post-dose on Day 5
Cmax on day 5
Maximum observed plasma concentration for dexlansoprazole
Measured: 12 hours post-dose on Day 5
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
Measured: 12 hours post-dose on Day 5
AUC(0-12h) on day 5
AUC from time 0 to the time of the last quantifiable concentration on day 5
Measured: 12 hours post-dose on Day 5
AUC(0-inf) on day 1
AUC from time 0 to extrapolated to infinity on day 1
Measured: 12 hours post-dose on Day 5
AUC(0-inf) on day 5
AUC from time 0 to extrapolated to infinity on day 5
Measured: 12 hours post-dose on Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start5 May 2017 (estimated)
- Primary completion31 Aug 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lihua Wu, Doctor, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120273
- Sponsor's protocol ID
- ASKC263-LC-1-2
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety in Healthy Chinese Adults After Multiple Intravenous Administration of Dexlansoprazole
- ClinicalTrials.gov ID
- NCT03120273
- Acronym / sponsor ID
- ASKC263-LC-1-2
- Conditions
- Effect of Drugs, Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Study start
- 5 May 2017 (estimated)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexlansoprazole Injection | Experimental | Drug: Dexlansoprazole Injection15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days |
| Lansoprazole Injection | Active comparator | Drug: Lansoprazole Injection30 mg q12h in lansoprazole treatment arm for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexlansoprazole Injection15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days | Drug | Dexlansoprazole Injection |
| Lansoprazole Injection30 mg q12h for 5 days. | Drug | Lansoprazole Injection |
Primary outcome
Percentage time with the intragastric potential of hydrogen (pH)>4
Time frame: 24 hours post-dose on Day 5
Duration of intragastric pH>4 within 24 hours postdose
Percentage time with the intragastric pH>6
Time frame: 24 hours post-dose on Day 5
Duration of intragastric pH>6 within 24 hours postdose
The time of the intragastric pH reaching 4
Time frame: 12 hours post-dose on Day 5
The time of intragastric pH reaching 4 after the last dose
The time of the intragastric pH reaching 6
Time frame: 12 hours post-dose on Day 5
The time of intragastric pH reaching 6 after the last dose
12 secondary outcomes
Mean intragastric pH
Time frame: 24 hours post-dose on Day 5
Mean intragastric pH per hour
Time frame: 24 hours post-dose on Day 5
Percentage time with the intragastric pH>4 during the first 4 hours
Time frame: 4 hours post-dose on Day 5
Percentage time with the intragastric pH>6 during the first 4 hours
Time frame: 4 hours post-dose on Day 5
Percentage of the participants with duration time of intragastric pH>4 over 12h
Time frame: 12 hours post-dose on Day 5
Percentage of the participants with duration time of intragastric pH>6 over 12h
Time frame: 12 hours post-dose on Day 5
Cmax on day 1
Time frame: 12 hours post-dose on Day 5
Cmax on day 5
Time frame: 12 hours post-dose on Day 5
Area under the plasma concentration-time curve (AUC) on day 1
Time frame: 12 hours post-dose on Day 5
AUC(0-12h) on day 5
Time frame: 12 hours post-dose on Day 5
AUC(0-inf) on day 1
Time frame: 12 hours post-dose on Day 5
AUC(0-inf) on day 5
Time frame: 12 hours post-dose on Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Derived from this study: PubMed 31338800Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lihua Wu, Doctor principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexlansoprazole Injection and Lansoprazole Injection in people with Effect of Drugs and Safety Issues, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lihua Wu, Doctor (86-13819195192, lihuawu73@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage time with the intragastric potential of hydrogen (pH)>4 (time frame: 24 hours post-dose on Day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.