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NCT01526317

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

NCT ID: NCT01526317

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR

Keywords

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Drug interaction Rosuvastatin Metformin SR Pharmacokinetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

This arm is consist of 6 subject. Crestor 10mg and Glucodown 750mg for 5 day during period 1. Crestor 10mg alone for 5 day during period 2. Glucodown 750mg alone for 5 day during period 3.

Group Type EXPERIMENTAL

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

Intervention Type 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.

2

This arm is consist of 6 subject. Glucodown 750mg alone for 5 day during period 1. Crestor 10mg and Glucodown 750mg for 5 day during period 2. Crestor 10mg alone for 5 day during period 3.

Group Type EXPERIMENTAL

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

Intervention Type 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.

3

This arm is consist of 6 subject. Crestor 10mg alone for 5 day during period 1. Glucodown 750mg alone for 5 day during period 2. Crestor 10mg and Glucodown 750mg for 5 day during period 3.

Group Type EXPERIMENTAL

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

Intervention Type 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.

4

This arm is consist of 6 subject. Glucodown 750mg alone for 5 day during period 1. Crestor 10mg alone for 5 day during period 2. Crestor 10mg and Glucodown 750mg for 5 day during period 3.

Group Type EXPERIMENTAL

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

Intervention Type 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.

5

This arm is consist of 6 subject. Crestor 10mg alone for 5 day during period 1. Crestor 10mg and Glucodown 750mg for 5 day during period 2. Glucodown 750mg alone for 5 day during period 3.

Group Type EXPERIMENTAL

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

Intervention Type 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.

6

This arm is consist of 6 subject. Crestor 10mg and Glucodown 750mg for 5 day during period 1. Glucodown 750mg alone for 5 day during period 2. Crestor 10mg alone for 5 day during period 3.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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Crestor 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyungsu Park, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Yonsei University

Locations

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Severance Hospital, Yonsei University

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee D, Roh H, Son H, Jang SB, Lee S, Nam SY, Park K. Pharmacokinetic interaction between rosuvastatin and metformin in healthy Korean male volunteers: a randomized, open-label, 3-period, crossover, multiple-dose study. Clin Ther. 2014 Aug 1;36(8):1171-81. doi: 10.1016/j.clinthera.2014.06.004. Epub 2014 Jun 26.

Reference Type DERIVED

PMID: 24976448 (View on PubMed)

Other Identifiers

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YH14755-101

Identifier Type: -

Identifier Source: org_study_id