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Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin

NCT01992211 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-07-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability of BCWP\_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to evaluate the food effect of Pharmacokinetic profile of BCWP\_C003 after administration.

Conditions

  • Healthy

Interventions

DRUG

Rosuvastatin

Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.

DRUG

Metformin

Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.

DRUG

BCWP_C003

Participant will be administered a single oral dose of BCWP\_C003 under Fasting condition or Fed condition according to sequence.

Sponsors & Collaborators

  • BC World Pharm Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, MD. PhD. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2017-04-28
Completion
2017-07-10

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01992211 on ClinicalTrials.gov