NCT02186483

Brief Summary

The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 29, 2018

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

July 4, 2014

Last Update Submit

March 28, 2018

Conditions

HyperlipidemiaDiabetes

Outcome Measures

Primary Outcomes (1)

  • Cmax,ss, AUCτ

    32h

Secondary Outcomes (5)

  • Tmax,ss

    32h

  • t1/2

    32h

  • Cmin,ss

    32h

  • CL/Fss

    32h

  • Vd/Fss

    32h

Study Arms (3)

Metformin

EXPERIMENTAL

Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration

Drug: MetforminDrug: RosuvastatinDrug: Metformin and Rosuvastatin

Rosuvastatin

EXPERIMENTAL

Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin

Drug: MetforminDrug: RosuvastatinDrug: Metformin and Rosuvastatin

Co-administration

EXPERIMENTAL

Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin

Drug: MetforminDrug: RosuvastatinDrug: Metformin and Rosuvastatin

Interventions

MetforminDRUG

Metformin,1000mg, once daily

Also known as: Glucodown OR SR tablet
Co-administrationMetforminRosuvastatin
RosuvastatinDRUG

Rosuvastatin, 20 mg, once daily

Also known as: Crestor tablet
Co-administrationMetforminRosuvastatin
Metformin and RosuvastatinDRUG

Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily

Also known as: Glucodown OR SR tablet and Crestor tablet
Co-administrationMetforminRosuvastatin

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \~55 years healthy male
  • BMI measurement 19.0kg/m\^2\~ 28.0kg/m\^2
  • Signed informed consent form from to participate voluntarily and to comply with the trial requirements.

You may not qualify if:

  • History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
  • SBP\>140mmHg or \<90mmHg, DBP\>90mmHg or \<60mmHg.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • History of drug abuse
  • A alcohol consumer(alcohol\>140g/week) or smoker(cigarette\>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
  • Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
  • Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
  • Glomerular filtration rate\<60mL/min
  • Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center(SMC)

Seoul, Gangnam-Gu, 135-710, South Korea

Location

MeSH Terms

Conditions

HyperlipidemiasDiabetes Mellitus

Interventions

MetforminRosuvastatin Calcium

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jung-ryul Kim, MD, Ph.D

    Samsung Medical Center(SMC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 10, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 29, 2018

Record last verified: 2014-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)