A Phase I Study of Nifekalant in Healthy Chinese Male Volunteers.

Phase 1

Suspended

• Conditions: Cardiovascular - Other cardiovascular diseases; Arrhythmias; ventricular tachycardia

• Registration Number: ACTRN12616000034437
• Lead Sponsor: Fuwai hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Suspended
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Healthy male Chinese volunteers between the ages of 19-40. Body mass index between 19 and 24 kg/m^2, nonsmokers, thorax radiography and electrocardiography without abnormalities, normal values of BP and heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing.

Exclusion Criteria

1, vital signs abnormal(SBP < 90mmHg or > 140mmHg, DBP < 50mmHg or > 90mmHg, HR < 50 bpm or > bpm).
2, Electrocardiographic abnormality with clinical significance or QTc interval > 400ms.
3, Holter monitor found sinus beat stop, third degree sinoatrial conduction block, atrioventricular block or heterotopic heart rate.
4, clinical significant allergies to drug or foods;
5, alcohol or drug abuse;
6, alcoholics or frequent drinkers 6 months before the study (that is 14 unit of alcohol weekly).
7, heavy smoker or smoking amount more than 5 cigarettes 3 months before the study
8, positive results on HIV and hepatitis types B and C testing
9, donate blood or participated in other clinical trials within 3 months before enrollment in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified