NCT03709355

Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs

Open-Label Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of ELPIDA® in Co-Administration With Other Drugs in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Viriom · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study assesses PK and safety of other drugs, such as some antibiotics, proton pump inhibitors, statins, and combined oral contraceptives when co-administered with Elpida®

Detailed description

This study evaluates the drug-drug interaction of Elpida® and other drugs (Rifampin, Rifabutin, Clarithromycin, Omeprazole, Atorvastatin and combinations of Levonorgestrel and Ethinylestradiol) according to changes in the PK parameters of the study substances in their single co-administration in healthy subjects

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Elpida®	Elpida® capsules, 20mg
DRUG	Rifampin	Rifampin capsules, 150mg
DRUG	Rifabutin	Rifabutin capsules, 150mg
DRUG	Clarithromycin	Clarithromycin Film-coated tablets, 250mg
DRUG	Omeprazole	Omeprazole Film-coated tablets 20mg
DRUG	Atorvastatin	Atorvastatin Film-coated tablets, 80mg
DRUG	Levonorgestrel+Ethinylestradiol	Levonorgestrel 150 μg + Ethinylestradiol 30 μg, Film-coated tablets

Timeline

• Start date: 2018-11-14
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2018-10-17
• Last updated: 2022-01-26

Locations

1 site across 1 country: Russia