NCT01775579

Brief Summary

We investigate the potential pharmacokinetic drug-drug interaction between metformin extended release and rosuvastatin in healthy male volunteers who receive metformin extended release alone, rosuvastatin alone, and both together in a 3 period repeatedly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Timeline
Completed

Started Jan 2013

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

Study Start

First participant enrolled

January 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

January 23, 2013

Last Update Submit

August 22, 2013

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Metformin, Rosuvastatin Cmaxss

    0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

  • metformin, rosuvastatin AUC

    0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

Secondary Outcomes (5)

  • Metformin, Rosuvastatin tmaxss

    0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

  • Metformin, Rosuvastatin t1/2

    0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

  • Metformin, Rosuvastatin C min,ss

    0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

  • Metformin, Rosuvastatin CL/Fss

    0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

  • Metformin, Rosuvastatin Vd/Fss

    0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

Study Arms (3)

Crestor tablet 20 mg

EXPERIMENTAL

Crestor tablet 20 mg single---\>wash out----\>Glucophage SR tablet 750 mg single----\>washout---\>Glucophage SR tablet 750 mg, Crestor tablet 20 mg both

Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Glucophage SR tablet 750 mg and Crestor tablet 20 mg both

EXPERIMENTAL

Glucophage SR tablet 750 mg, Crestor tablet 20 mg both---\>wash out----\>Glucophage SR tablet 750 mg single------\>washout---\>Crestor tablet 20 mg single

Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Glucophage SR tablet 750 mg

EXPERIMENTAL

Glucophage SR tablet 750 mg single ---\>wash out----\>Crestor tablet 20 mg single----\>washout---\>Glucophage SR tablet 750 mg, Crestor tablet 20 mg both

Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Interventions

Glucophage SR tablet 750 mg, Crestor tablet 20 mgDRUG
Crestor tablet 20 mgGlucophage SR tablet 750 mgGlucophage SR tablet 750 mg and Crestor tablet 20 mg both

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers, age 20 to 55 years.
  • The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

You may not qualify if:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
  • Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
  • Systolic blood pressure \<90mmHg or Diastolic blood pressure \< 60 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samgsung Seoul Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

January 23, 2013

First Posted

January 25, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations

KR(1)