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Single center, open-label, single and combined dose, pharmacokinetic study to evaluate of Allisartan tablets and Indapamide tablets in healthy subjucts

Single center, open-label, single and combined dose, pharmacokinetic study to evaluate of Allisartan tablets and Indapamide tablets in healthy subjucts

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039179
Enrollment
Unknown
Registered
2020-10-21
Start date
2020-10-26
Completion date
Unknown
Last updated
2021-01-18

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

Conditions

Hypertension

Interventions

experimental group:allisartan 240mg, indapamide 1.5mg

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Inform concerned prior to screening, acknowledgement of protocol, procedure and AE; 2. Able to complete the study follow by the protocol; 3. Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening to the last study drug administration. See Appendix for specific contraceptive measures; 4. Male and female subjects aged 18-45 (including 18 and 45 years old); 5. The body weight of male subjects is no less than 50kg, and that of female subjects is no less than 45kg; body mass index (BMI) = body weight (kg) / height 2 (M2), body mass index is in the range of 18-28kg / m2 (including the critical value); 6. Physical examination and vital signs are normal or abnormal without clinical significance; systolic blood pressure > 100 and = 60 and < 90mmHg, without postural hypotension. 7. 3.5<=blood potassium<=5.5mmol/L.

Exclusion criteria

Exclusion criteria: 1. The subjects who smoked more than 5 cigarettes per day in the three months before the experiment and could not guarantee to quit smoking during the experiment; 2. Those who are known or suspected to have allergic reactions to allisartan, losartan, indapamide and their accessories of the product; or ARB, or Thiazides and thiazines or allergic constitution (multiple drugs and food allergy); 3. Subjects with a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits, or 100 ml of wine); 4. Blood donation or massive blood loss within three months before screening (> 450 ml); 5. Difficulty in swallow or any stomach diseases that influence the absorption of drugs; 6. Any risks of bleeding diseases, such as Hemorrhoids, acute gastritis or gastric and duodenal ulcer.

Design outcomes

Primary

MeasureTime frame
Cmax,ss;AUC0-tau,ss;

Countries

China

Contacts

Public ContactYing Wang

Zhejiang Provincial People's Hospital

nancywangying@163.com+86 18367124548

Outcome results

None listed

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