BioavailabilityEarly Phase 1NCT03794843
Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers
A Early Phase 1 study testing Nimodipine Injection and Nimodipine Injection (II) in people with Bioavailability and Safety Issues, run by Shenyang Dongxing Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioavailability, Safety Issues, Ischemic Cerebrovascular Disease
- What is being tested?
- Nimodipine Injection and Nimodipine Injection (II)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2018to Jun 2019
- Phase
- Early 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
- Sign the informed consent form before the study, and fully understand the test content, process and possible adverse reactions, and be able to comply with the protocol according to the test plan requirements;
- Healthy subjects, both male and female;
- Age ≥ 18 years old;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index in the range of 19 ~ 26 (including the critical value)[Body mass index (BMI) = weight (kg) / height 2 (m2)].
Who cannot join
- Subject who is in one of the following conditions may not be eligible.
- Those who smoke more than 5 cigarettes per day for 3 months before the test or who cannot stop smoking during the trial period;
- Allergies, such as those who are allergic to drugs, food and pollen, or those known to be allergic to nimodipine;
- Those who have a history of alcohol abuse 6 months before the test (defined as drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, or high-alcohol (50% or more alcohol) 25 ml, or 150 ml of wine) or Drinkers cannot be stopped during the trial;
- Donor blood or a large amount of blood loss ≥400 ml (excluding female menstrual blood volume) within 3 months before the test, or have a history of halo and fainting;
- Anyone taking any drug within 14 days before the test;
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- Antidepressants (such as fluoxetine), nortriptyline, norfloxacin, anti-HIV drugs (such as azidothymidine), calcium antagonists (such as nifedipine), were used within 28 days prior to the test. Diltiazem, verapamil, alpha-methyldopa and other antihypertensive drugs;
- Have taken the study drug within 3 months before the test, or participated in any drug or medical device clinical trial;
- Clinical laboratory examination, vital signs, physical examination, and 12-lead ECG abnormalities in the screening period are clinically significant;
- During screening, when staying in the clinical center, the supine pressure of the supine position is not in the range of 100~139 mmHg, and the diastolic pressure in the supine position is not in the range of 60~89 mmHg;
- During screening, when staying in the clinical center, the pulse is not in the range of 60~100 beats/min before each dose;
- There is a serious arrhythmia: QTc interval prolongation (QTc over 450 ms), or QTc interval prolongation syndrome or family history of sudden death
- A positive result of screening for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or Treponema pallidum-specific antibody;
- Health status: a history of major diseases or important organ diseases such as nervous system, mental system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal or metabolic abnormalities;
- pregnant and lactating women;
- Female subjects of childbearing age have a pregnancy plan or unable to take effective contraception after the first dose and within 3 months after the last dose, from 30 days before screening to 3 months after the last dose. Measures (non-pharmaceutical contraception), see the appendix for specific contraceptive measures;
- Can not stop taking chocolate, any caffeinated food or drink during the test; or eat any food or drink containing grapefruit ingredients 14 days before the first dose to the end of the test;
- Those who are positive for alcohol screening before dosing, or who have taken any alcoholic products within 24 hours prior to dosing;
- Those who are positive for drug screening, who have had a history of drug abuse in the past five years or who have used drugs three months before the trial;
- Investigators believe that it is not appropriate to participate in this test
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
ZHANG LAN, doctor, 010-83198855, xwphase1@163.com
About this study
Official title: A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers
A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.
Read the detailed description
The investigation product Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd.And Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation.The volunteers were administered with Nimodipine injection for intravenous infusion (containing nimodipine 11 mg) for 12 consecutive hours, respectively.The Venous blood was collected at 0 hours before the administration (ie, 1 hour before the administration) and 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h (Administration was over) and 12.5 h, 13 h, 14 h, 16 h, 19 h, 22 h, 25 h, 36 h, 3 ml per blood collection.
- Being tested
- Nimodipine Injection, Nimodipine Injection (II)
- Keywords
- Nimodipine, bioavailability, Safety, ischemic cerebrovascular disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimodipine InjectionDrug
Also called Nimotop
Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation
Nimodipine Injection (II)Drug
Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd
| Study group | Role | What they receive |
|---|---|---|
| Nimodipine Injection (II) | Experimental | The specification of this injection is 5 ml: 4 mg , which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:16 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine. Receives: Drug: Nimodipine Injection (II) |
| Nimodipine Injection | Experimental | The specification of this injection is 50 ml: 10 mg ,which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:4 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine. Receives: Drug: Nimodipine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Evaluation of bioequivalence based on pharmacokinetic parameters such as AUC
Measured: Within 36 hours after starting the administration
Cmax
Evaluation of bioequivalence based on pharmacokinetic parameters such as Cmax
Measured: Within 36 hours after starting the administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start23 Aug 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Dongxing Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794843
- Sponsor's protocol ID
- BJK-PK-NMDP-201801
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03794843
- Acronym / sponsor ID
- BJK-PK-NMDP-201801
- Keywords
- Nimodipine, bioavailability, Safety, ischemic cerebrovascular disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shenyang Dongxing Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 Jan 2019 (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.
A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.
Detailed description
The investigation product Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd.And Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation.The volunteers were administered with Nimodipine injection for intravenous infusion (containing nimodipine 11 mg) for 12 consecutive hours, respectively.The Venous blood was collected at 0 hours before the administration (ie, 1 hour before the administration) and 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h (Administration was over) and 12.5 h, 13 h, 14 h, 16 h, 19 h, 22 h, 25 h, 36 h, 3 ml per blood collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimodipine Injection (II) | Experimental | Drug: Nimodipine Injection (II)The specification of this injection is 5 ml: 4 mg , which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:16 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine. |
| Nimodipine Injection | Experimental | Drug: Nimodipine InjectionThe specification of this injection is 50 ml: 10 mg ,which is administered by constant infusion intravenously with an infusion pump. The injection and 0.9% sodium chloride injection is simultaneously infused at a ratio of 1:4 (injection: combined infusion). The rate of intravenous drip was started at 0.5 mg/h for 2 hours, and the rate of intravenous drip was 1.0 mg/h after 2 hours, and continuous infusion for 12 hours, for a total of 11 mg of nimodipine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign the informed consent form before the study, and fully understand the test content, process and possible adverse reactions, and be able to comply with the protocol according to the test plan requirements;
- Healthy subjects, both male and female;
- Age ≥ 18 years old;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index in the range of 19 ~ 26 (including the critical value)[Body mass index (BMI) = weight (kg) / height 2 (m2)].
Key exclusion criteria (20 listed)
- Subject who is in one of the following conditions may not be eligible.
- Those who smoke more than 5 cigarettes per day for 3 months before the test or who cannot stop smoking during the trial period;
- Allergies, such as those who are allergic to drugs, food and pollen, or those known to be allergic to nimodipine;
- Those who have a history of alcohol abuse 6 months before the test (defined as drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, or high-alcohol (50% or more alcohol) 25 ml, or 150 ml of wine) or Drinkers cannot be stopped during the trial;
- Donor blood or a large amount of blood loss ≥400 ml (excluding female menstrual blood volume) within 3 months before the test, or have a history of halo and fainting;
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 |
|---|---|---|
| Nimodipine InjectionAlso: NimotopNimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation | Drug | Nimodipine Injection |
| Nimodipine Injection (II)Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd | Drug | Nimodipine Injection (II) |
Primary outcome
AUC
Time frame: Within 36 hours after starting the administration
Evaluation of bioequivalence based on pharmacokinetic parameters such as AUC
Cmax
Time frame: Within 36 hours after starting the administration
Evaluation of bioequivalence based on pharmacokinetic parameters such as Cmax
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nimodipine Injection and Nimodipine Injection (II) in people with Bioavailability and Safety Issues, run by Shenyang Dongxing Pharmaceutical Technology Co., Ltd. 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 4 inclusion and 20 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 8 Jan 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Zhang Lan, Doctor (+86-010-83198855, xwphase1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: Within 36 hours after starting the administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2019.