Status:
COMPLETED
A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers
Lead Sponsor:
Yuhan Corporation
Conditions:
Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01526317
Start Date
December 1 2011
End Date
May 1 2012
Last Update
August 1 2012
Active Locations (1)
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1
Severance Hospital, Yonsei University
Seoul, South Korea, 120-752