NCT04185090

To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults

An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

Detailed description

An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects

Conditions

• Hypertension
• Dyslipidemias

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ID1803	Amlodipine 10mg/Valsartan 160mg
COMBINATION_PRODUCT	ID1801	Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
COMBINATION_PRODUCT	ID1803+ID1801	Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-12-04
• Last updated: 2019-12-26