A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers
This study has been completed.
Sponsor:
Yuhan Corporation
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01526317
First received: February 1, 2012
Last updated: July 31, 2012
Last verified: July 2012
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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:
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 (Adult) |
| 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
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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
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
|
Metformin Rosuvastatin Calcium Hypoglycemic Agents Physiological Effects of Drugs Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on September 26, 2016