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Pharmacokinetics study to compare Allisartan with Losartan

Pharmacokinetics study to compare Allisartan with Losartan

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027242
Enrollment
Unknown
Registered
2019-11-06
Start date
2019-11-29
Completion date
Unknown
Last updated
2019-11-11

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

Conditions

Hypertension

Interventions

A:phase I: Allisartan
phase II: Losartan
B:phase I: Losartan
phase II: Allisartan.

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)Aged 18-65 years (including 18 and 65 years old), gender including men and women; 2)Body weight: Men >= 50kg, Women >=45kg, BMI=kg/m^2, 19-26kg/m^2 (including 19-26 kg/m^2); 3)Voluntary signing of informed consent

Exclusion criteria

Exclusion criteria: 1) Any clinically serious disease that has been or is currently suffering from the circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic abnormalities or can interfere with the test results. Any other disease; 2) Have a history of allergies to drugs, food or other substances; 3) Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study; 4) Those who have taken any drugs or health care products (including Chinese herbal medicines) within 14 days before the test; 5) Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones; 6) Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial; 7) Donate blood or a large amount of blood loss ( >=200 mL), receive blood transfusion or use blood products within 3 months before enrollment; 8) Pregnant or lactating women, and those who are unable to use one or more non-pharmaceutical contraceptives during the volunteer trial; 9) Those who have special requirements for diet and cannot follow the unified diet; 10) Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; 11) Those who smoke more than 5 cigarettes per day for the first 3 months of the trial or who cannot stop using any tobacco products during the trial period; 12) Alcoholics or those who regularly drink alcohol within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or during the test period Stop using any alcoholic products; 13) Drug abusers or soft drugs (such as marijuana) used 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 14) Abnormal vital signs (SBP 140 mmHg, DBP 90 mmHg; heart rate 100 bpm) or physical examination, electrocardiogram, laboratory examination abnormalities are clinically significant (Subject to the judgment of the clinical research doctor); 15) Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.

Design outcomes

Primary

MeasureTime frame
Cmax;AUC0-t;AUC0-8;

Countries

China

Contacts

Public ContactGuoping Yang

The Third Xiangya Hospital of Central South University

ygp9880@163.com+86 13974817168

Outcome results

None listed

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