Skip to content

Single center, open-label, steady state, single dose and combine dose, phase I study for pharmacokinetics of Allisartan tablets and Amlodipine tablets in healthy volunteers

Single center, open-label, steady state, single dose and combine dose, phase I study for pharmacokinetics of Allisartan tablets and Amlodipine tablets in healthy volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026661
Enrollment
Unknown
Registered
2019-10-17
Start date
2019-10-16
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

Hypertension

Interventions

Case series:Allisartan, amlodipine

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Signed consent inform, acknowledge of content, procedure and potential adverse reactions of study; 2. Followed by study protocol and complete study; 3. Subjects (including their partners) have no pregnancy plan and voluntary to take effective contraceptive measures 4. Aged 18 to 45 years old (including 18 and 45 years old); 5. Body weight: Men >= 50kg, BMI=kg/m^2, 18-28 kg/m^2 (including 18-28 kg/m^2); 6. Normal hysical examination, vital sign or abnormal but no clinical significance. SBP 100~139, DBP 60~90.

Exclusion criteria

Exclusion criteria: 1. Amount of smoking >5 cigarets per day within 3 months prior to study; 2. Allergy to alisartan, losartan, amlodipine and their integridients; 3. History of drugs addicted and/or alcohol abuse (14 units of alcohol per week: 1 unit=285 mL of beer, or 25 mL of liquor, or 100 mL red wine); 4. Blood donation or blood lossing > 450mL prior to administration of drugs; 5. Difficulty in swallowing or history of any GI diseases affecting the absorption of drugs; 6. High risk in bleeding.

Design outcomes

Primary

MeasureTime frame
Cmax;AUC;

Countries

China

Contacts

Public ContactYanhua Ding

The First Hospital of Jilin University

dingyanhua2003@126.com+86 18186879768

Outcome results

None listed

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