Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects

Overview[ - collapse ][ - ]

Purpose The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers
ConditionHealthy
InterventionDrug: Period I : atorvastatin, Period II : atorvastatin and metformin
Drug: Period I : metformin, Period II : atorvastatin and metformin
PhasePhase 1
SponsorCJ Cheiljedang Corporation
Responsible PartyCJ Cheiljedang Corporation
ClinicalTrials.gov IdentifierNCT01765023
First ReceivedDecember 12, 2012
Last UpdatedApril 7, 2013
Last verifiedApril 2013

Tracking Information[ + expand ][ + ]

First Received DateDecember 12, 2012
Last Updated DateApril 7, 2013
Start DateOctober 2012
Estimated Primary Completion DateJanuary 2013
Current Primary Outcome MeasuresTo Evaluate PK interaction of atorvastatin and metformin [Time Frame: Throughout the study] [Designated as safety issue: No]
Current Secondary Outcome MeasuresTo Evaluate PK interaction of 2-OH-atorvastatin and metformin [Time Frame: Throughout the study] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitlePharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
Official TitleAn Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
Brief Summary
The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin
and metformin single or co-administered in healthy volunteers
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
ConditionHealthy
InterventionDrug: Period I : atorvastatin, Period II : atorvastatin and metformin
Drug: Period I : metformin, Period II : atorvastatin and metformin
Study Arm (s)
  • Experimental: Part A
    single administration : atorvastatin 40mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral)
  • Experimental: Part B
    single administration : metformin XR 1000mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment80
Estimated Completion DateJanuary 2013
Estimated Primary Completion DateDecember 2012
Eligibility Criteria
Inclusion Criteria:

1. Willing to adhere to protocol requirements and sign a informed consent form

2. Healthy male volunteers who are in age range of 20-55 years and the weight range is
not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9

3. Subjects with no history of any significant chronic disease

4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and
routine laboratory data for this trial by investigators

Exclusion Criteria:

1. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital
within 28days prior to study medication dosing

2. Subjects with Symptoms of acute disease within 28days prior to study medication
dosing

3. Subjects with a history of gastrointestinal diseases which might significantly change
ADME of medicines

4. Subjects with a history of abdominal surgery within food and water limit

5. Subjects with a history of clinically significant allergies including drug allergies

6. Subjects with anaphylaxis to atorvastatin and/or metformin

7. Subjects with a history or plan iodine radiotherapy within 28 days prior to drug
administration

8. Subjects with a history of myopathy

9. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase
deficiency or glucose-galactose malabsorption

10. Clinical laboratory test values are outside the accepted normal range

- AST or ALT >1.25 times to normal range

- Total bilirubin >1.5 times to normal range

- Creatinine clearance <90 mL/min

11. Subjects with a history of drug, caffeine and alcohol abuse(caffeine > 5cups/day,
cigarette > 10/day, alcohol > 30g/day) or have ever drank within 7 days prior to drug
administration

12. Special diet known to interfere with the absorption, distribution, metabolism or
excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior
to drug administration

13. Donated blood within 60 days prior to dosing

14. Participated in a previous clinical trial within 60 days prior to dosing

15. Subjects who have received any drugs that might confound the results of the trial
based on medical judgement by investigators within 10days prior to drug
administration

16. Subjects considered as unsuitable based on medical judgement by investigators
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01765023
Other Study ID NumbersCJ_ATM_101
Has Data Monitoring CommitteeNo
Information Provided ByCJ Cheiljedang Corporation
Study SponsorCJ Cheiljedang Corporation
CollaboratorsNot Provided
Investigators Not Provided
Verification DateApril 2013

Locations[ + expand ][ + ]

Inje University Pusan Paik Hospital
Busan, Korea, Republic of, 614-735