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Open, parallel, single dose and multiple dose, dose escalation of hydrochloric acid test Nifatan injection in Chinese healthy volunteers the pharmacokinetic study

Open, parallel, single dose and multiple dose, dose escalation of hydrochloric acid test Nifatan injection in Chinese healthy volunteers the pharmacokinetic study

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-16008035
Enrollment
Unknown
Registered
2016-03-01
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic, such as capacity or high volume hyponatremia

Interventions

GroupA:PK test of intravenous infusion of a single dose of 10 mg
GroupB:PK PK test. A single dose of intravenous injection of 20 mg, washout period after intravenous injection of 20 mg (loading dose) then slowly intravenous injection of 20 mg 4 times (maintenance d
GroupC:PK test of intravenous infusion of a single dose of 40 mg

Sponsors

Beijing An Zhen Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: All meet the following criteria can be selected: 1 volunteered to participate in this clinical trial, and signed informed consent 2 China male or female subjects 3 age 18~45 4.Body mass index (BMI) within the scope of the 19 ~ 24 kg/m2, BMI = weight (kg)/height 2 (m2), and not less than 50 kg weight

Exclusion criteria

Exclusion criteria: Following any one who cannot be enrolled in this study: 1 any may affect the safety and drug in the body's disease history 2 Currently has any instability or recurrent disease, or affect the disease in the process of drug in the body 3 screening of blood pressure and heart rate in the following period does not check the normal range: Sitting systolic blood pressure: 90-140 mmHg: 60-90 mmHg, diastolic blood pressure, heart rate less than 100 BPM 4 the serum sodium was higher than 145mmol/l 5 orthostatic hypotension, dizziness or vertigo history history 6. Allergic / hypersensitivity reaction (including the drugs or excipients, food allergies), history of allergy history and specific reaction of benzo aza Zhuo or its derivatives (benazepril) 7 a month before the administration of drugs in clinical trials Participated in other clinical trials in the 8 clinical trials administered within 3 months before or during the test plan to participate in other clinical trials 9 smokers 10 test (during the screening period to the end of follow-up) can't quit smoking 11 alcoholics 12 test (during the screening period to the end of follow-up) cannot abstainer 13 drug abusers, or urine drug screening test positive 14 cannot comply with the diet research center of the 15 in the test within 3 months before the blood donation of more than 200 mL, blood donors testing or during the test, after the end of 1 months 16 in this test administered 1 weeks before or during the test of excessive physical labor or exercise. 17 physical examination, ECG, chest X-ray examination and clinical significance of abnormal 18 laboratory tests (blood routine, urine routine, liver and kidney function, blood glucose, blood lipid, abnormal ion) and the clinical significance. 19 hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody test positive results 20 pregnant or lactating women 21 In addition to the above, the researchers do not consider it appropriate to take the test subjects

Design outcomes

Primary

MeasureTime frame
Blood drug concentration;

Countries

China

Contacts

Public ContactLin Yang
linyang@anzhengcp.com+86 13701073623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026