Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers

NCT03794843 | Unknown Early Phase 1

• 1 other identifier: BJK-PK-NMDP-201801
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioavailability; Safety Issues; Ischemic Cerebrovascular Disease

Keywords

Nimodipine; bioavailability; Safety; ischemic cerebrovascular disease

Outcome Measures

Primary Outcomes (2)

• AUC

  Evaluation of bioequivalence based on pharmacokinetic parameters such as AUC

  Within 36 hours after starting the administration

• Cmax

  Evaluation of bioequivalence based on pharmacokinetic parameters such as Cmax

  Within 36 hours after starting the administration

Study Arms (2)

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.

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.

Drug: Nimodipine Injection

Interventions

Nimodipine Injection DRUG

Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation

Also known as: Nimotop

Nimodipine Injection

Nimodipine Injection (II) DRUG

Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd

Nimodipine Injection (II)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)\[Body mass index (BMI) = weight (kg) / height 2 (m2)\].

You may not qualify if:

• \- 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;
• 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;

Sponsors & Collaborators

• Shenyang Dongxing Pharmaceutical Technology Co., Ltd.: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Interventions

Nimodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids

Central Study Contacts

Zhang Lan, Doctor

CONTACT

+86-010-83198855; xwphase1@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: August 23, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)