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A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers

NCT02561884 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-09-28

No results posted yet for this study

Summary

To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.

Conditions

  • Healthy

Interventions

DRUG

Olostar Tab.

DRUG

Co-administration of Olmetec and Crestor

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

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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 NCT02561884 on ClinicalTrials.gov