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Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers

NCT03699774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-02-12

No results posted yet for this study

Summary

The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin.

The total length of time (from screening to follow-up) for each participant is approximately 7 weeks.

It is expected that repeated oral doses of DS-8500a will not have a significant effect on the pharmacokinetics of a single dose of rosuvastatin.

Conditions

  • Drug Pharmacokinetics in Healthy Volunteers

Interventions

DRUG

DS-8500a

DS-8500a is provided as three 25-mg tablets for oral administration

DRUG

Rosuvastatin

Rosuvastatin is provided as a 10-mg tablet for oral administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Study Leader · Daiichi Sankyo

Study Design

Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2015-05-12
Primary Completion
2015-07-06
Completion
2015-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03699774 on ClinicalTrials.gov