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

Purpose

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.

Condition	Intervention	Phase
Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR	Drug: Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg)	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Randomized, Open Label, Cross-over Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Metformin Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:

AUCtau [ Time Frame: 72 hr ] [ Designated as safety issue: No ]
Css,max [ Time Frame: 72 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AUCss,last [ Time Frame: 72 hr ] [ Designated as safety issue: No ]
AUCss,inf [ Time Frame: 72 hr ] [ Designated as safety issue: No ]
Css,min [ Time Frame: 72 hr ] [ Designated as safety issue: No ]
Tss,max [ Time Frame: 72 hr ] [ Designated as safety issue: No ]
t1/2 [ Time Frame: 72 hr ] [ Designated as safety issue: No ]


Enrollment:	36
Study Start Date:	December 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.

Eligibility


Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526317

Locations


Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yuhan Corporation

Investigators


Principal Investigator:	Kyungsu Park, MD, Ph.D	Severance Hospital, Yonsei University

More Information

No publications provided by Yuhan Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Yuhan Corporation
ClinicalTrials.gov Identifier:	NCT01526317 History of Changes
Other Study ID Numbers:	YH14755-101
Study First Received:	February 1, 2012
Last Updated:	July 31, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:


Drug interaction Rosuvastatin Metformin SR Pharmacokinetic

Additional relevant MeSH terms:


Rosuvastatin Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors	Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015