NCT02786082

Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers

Single Center, Randomized, Open Labeled Pharmacokinetics Study of Azilsartan Tablets in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective is to study the pharmacokinetics of Azilsartan Tablets in human and providing evidence for clinical study and clinical application of this product.

Detailed description

This is a Single center, randomized, open labeled study. The study is conducted to evaluate the pharmacokinetics Studies of Azilsartan with single-dose oral administration, multiple-dose oral administration and effects of diet. 1\) Pharmacokinetics Studies of Azilsartan with Single-dose oral administration: 24 healthy subjects will be randomly divided into 2 groups evenly, Group I and Group II, with 12 subjects in each group, half are male and half are female. Group I will take Azilsartan tablet 20mg orally on fasting, while Group II will take Azilsartan tablet 40mg orally on fasting. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature. 2）Pharmacokinetic Studies of Azilsartan Tablets with Multiple-dose oral administration Subjects in Group I will take 20mg Azilsartan orally once daily for 7 day (day 3\~day 9) after completing the last time blood sample collection (in day 2, 48h) of the first time administration (day 1). 5mL blood sample will be collected from vein on day 7, day 8 and day 9 for measuring minimum observed concentration before drug administration. On day 9, after administration, blood sampling time is the same as single-dose administration study. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature. 3）The effects of diet for pharmacokinetic study: The 12 healthy subjects, in group II (in single-dose administration study), after 7-day washout period after the first administration (at day 1, 40mg) will receive Azilsartan tablet 40mg after high-fat diet at day 8, and the blood sampling time point after administration is the same as in single-dose administration study. The process, storage condition of the blood samples are the same as single-dose administration study. Blood sampling time: 0h (before administration starting), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48h after administration. 5ml whole blood from cubital vein will be placed in a heparinized tube and centrifuged. Duplicated plasma A and B will be taken and kept in low temperature.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	20mg Azilsartan Tablets	Strength: 20mg, oral administration 1 tablet/ day
DRUG	40mg Azilsartan Tablets	Strength: 40mg, oral administration 1 tablet/ day

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-08-31
• Completion: 2017-11-30
• First posted: 2016-05-30
• Last updated: 2018-09-05