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Tolerability and Pharmacokinetics of Azilsartan Trimethylethanolamine to healthy Chinese subjects in a single-center, open-label, randomized, multiple-dose Phase Id study

Tolerability and Pharmacokinetics of Azilsartan Trimethylethanolamine to healthy Chinese subjects in a single-center, open-label, randomized, multiple-dose Phase Id study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-14005344
Enrollment
Unknown
Registered
2014-04-01
Start date
2014-09-29
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

Hypertension

Interventions

Case series:single-dose 70mg everyday for seven days

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 45 years, BMI 19 to 25 (including 19 and 25), and more than 50 kg weight; 2. To conduct a comprehensive physical examination before test (Height, weight, breathing, pulse, blood pressure and the chest examination, etc.) and laboratory examination (blood routine, urine routine, stool routine, blood biochemistry, blood coagulation and infectious disease test, etc.) are eligible. 12 lead ECG, abdominal B-ultrasound and chest X-ray examination without exception or slightly abnormal but without clinical significance; 3. No participation in another trial with an investigational drug or blood donation within three months; 4. Comprehend details the nature, significance, may benefit, might inconvenience and potential danger before partcipate in trial. Understand the research program and voluntary signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Any finding of the medical examination (including physical examination, laboratory tests and 12 lead ECG, abdominal B-ultrasound, chest X-ray); 2. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders; 3. Systolic blood pressure less than 100 mmHg or more than 130mmHg and diastolic blood pressure less than 70 mmHg or more than 90mmHg, relevant orthostatic hypotension; 4. Positive pregnancy test, pregnancy, Lactation period or planning to become pregnant during six months; 5. Intake of drugs with a long half-life or participation in another trial with an investigational drug or blood donation within three months; 6. Before randomization 2 weeks used special diet (including pitaya mango grapefruit and/or xanthine eating chocolate caffeinated coffee or tea, or any food or drinks containing caffeine, etc.) or strenuous exercise, or other factors influencing the distribution of drug absorption, metabolism, excretion etc.

Design outcomes

Primary

MeasureTime frame
Blood Pressure;ECG;Pulse;

Countries

China

Contacts

Public ContactXinghe Wang
wangxinghe@bjsjth.cn+86 010-63926401

Outcome results

None listed

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