Completed

NCT Number: NCT01526317

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

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.

Completed

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Key information

Conditions

Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital, Yonsei University

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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.

Primary outcomes

AUCtau

Time frame: 72 hr
Css,max

Time frame: 72 hr

Secondary outcomes

AUCss,last

Time frame: 72 hr
AUCss,inf

Time frame: 72 hr
Css,min

Time frame: 72 hr
Tss,max

Time frame: 72 hr
t1/2

Time frame: 72 hr

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 3, 2012
Registry last updated: Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.