Skip to content

Pharmacokinetics of Ivabradine Hemisulfate Extended-Released tablets in healthy Chinese volunteers

Pharmacokinetics of Ivabradine Hemisulfate Extended-Released tablets in healthy Chinese volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-14005034
Enrollment
Unknown
Registered
2014-07-31
Start date
2014-08-01
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

cardiovascular

Interventions

Group A:The doses were administered with sequence (5mg
Group B:The doses were administered with sequence (5mg
Group C:The doses were administered with sequence (15mg
10mg ) in four periods

Sponsors

The first affiliated hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 30 Years

Inclusion criteria

Inclusion criteria: (1) Healthy male and female volunteers; (2) Aged 18-40 years, with a group of subjects no younger than 10 years of age; (3) Body mass index (BMI) in the context of 19-25 kg/m2, (BMI= weight (kg)/height (m2)); (4) Vonlunteers could communicate well with the researchers and comply with the requirements of the entire study; (5) Written informed consent was obtained from all subjects prior to enrolment.

Exclusion criteria

Exclusion criteria: (1) Subjects had a history of hypersensitivity, allergy, serious adverse drug reaction, especially to penicillin drugs; (2) Participated in other clinical trials within three months; (3) Donated blood within one month, or plan to donate blood during the trial or within 1 month at the end of the trial; (4) Had received other drugs in clinical trials by vaccination or participate within nearly four weeks ; Taking any drugs within nearly four weeks; (5) Hypotension and/or a history of orthostatic hypotension; (6) Subjects had a history of Bradycardia, sinus arrest, sinoatrial block, atrioventricular block, a history of ectopic rhythm; (7) Any history of severe disease or medical history of cardiovascular system, endocrine system, nervous system, lung, hematology, immunology, pathergasiology and metabolic disturbance; (8) Any history of heart, liver, kidney, gastrointestinal tract, nervous system, metabolic disorders and other psychiatric disorders; (9) Subjects had Ocular diseases; (10) The general examination and blood pressure, heart rate and respiratory conditions did not meet with standards; (11) subjects had a history or evidence of any clinically significant diseases by direct medical history questioning and physical examination; (12) Laboratory tests (blood and urine routine, liver and kidney function, ECG and HIV et. al) found hematological abnormalities, heart, liver and kidney dysfunction; (13) Smoking, drinking or drug addiction prior to or during the study; (14) Unsuitable to participate in the trial considered by the researchers.

Design outcomes

Primary

MeasureTime frame
AUCtn;Cmax;Tmax;t1/2z;CLz/F;Vz/F;AUCss;

Contacts

Public ContactJianzhong Shentu
stjz@zju.edu.cn+86 571 87236560

Outcome results

None listed

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