A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers

A Randomized, Open Label, Cross-over Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526317

Enrollment

Registered

2012-02-03

Start date

2011-12-31

Completion date

2012-05-31

Last updated

2012-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR

Keywords

Drug interaction, Rosuvastatin, Metformin SR, Pharmacokinetic

Brief summary

This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also investigate drug interaction between separate and combination administration. Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day administration, 10 days washout after 5th day of administration. All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each period.

Interventions

DRUGCrestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg)

For co-administration,Crestor 1 tablet and Glucodown 1 tablet a day for 5 day.(1 period) For separate administration, Crestor 1 tablet a day for 5 day and Glucodown 1 tablet a day for 5 day.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 20\ 50 yrs old, healthy Korean Subjects * Body weight \<ideal body weight±20% * No congenital, chronic disease, No current disease * Subjects who are diagnosed to include by medical doctor from laboratory and ECG result. * Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion criteria

* Subjects who are allergic to investigational drug. * Subjects who have a medical history which can affect the clinical trial. * Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg) * Subjects who have taken other medicine in recent 2\ 4 weeks. * Subjects who have a risk of hypoglycemia and imbalance in taking a diet.

Design outcomes

Primary

Measure	Time frame
AUCtau	72 hr
Css,max	72 hr

Secondary

Measure	Time frame
AUCss,last	72 hr
Tss,max	72 hr
Css,min	72 hr
AUCss,inf	72 hr
t1/2	72 hr

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026