NCT04411875

Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects

Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 19 Years – 48 Years
• Healthy volunteers: Accepted

Summary

The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the random table generate by SAS 9.4, the subjects were divided into two groups at the ratio of 1:1. The select qualified volunteers were hospitalized in the Phase I Clinical Research Center, and fasted for 10 hours overnight until administration. The medicine was swallowed with 240 ml water at room temperature. Blood samples were taken before administration and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours after administration. The samples were centrifuged at 1,800 g for 10 min at 4 °C to separate the plasma. The plasma samples were divided into two aliquots and stored at -80 °C until bioanalysis. The half-life of levamlodipine is 30 \~ 50 hours. Washout period, the interval between two administration, is 21 days. In the two periods, the operation was kept the same. Moreover, in high fat meal group, the high-fat breakfast was arranged within half an hour before taking the medicine. Other procedures were the same as those in the fasting group.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Amlodipine 10 mg	The subjects randomly received single oral administration of amlodipine 10 mg.
DRUG	Levamlodipine 5 mg	The subjects randomly received single oral administration of levamlodipine 5 mg.

Timeline

• Start date: 2018-11-13
• Primary completion: 2019-01-15
• Completion: 2019-02-15
• First posted: 2020-06-02
• Last updated: 2020-06-05

Locations

1 site across 1 country: China