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

NCT03709355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-01-26

No results posted yet for this study

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®

Conditions

Interventions

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

Sponsors & Collaborators

  • Viriom

    lead INDUSTRY

Principal Investigators

  • Elena Smolyarchuk, PhD · I.M. Sechenov First Medical State University

  • Alla Andreeva, PhD · Smolensk Region Clinical Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2019-09-06
Completion
2019-09-06

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709355 on ClinicalTrials.gov