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Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 20mg

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ClinicalTrials.gov Identifier: NCT01929512
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
To compare the pharmacokinetic characteristics between HCP1201 tablet 750/20 mg and co-administration of metformin 750 mg plus rosuvastatin 20 mg under fasted and fed state, respectively.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: HCP1201 750/20mg Drug: Metformin SR 750mg Drug: Rosuvastatin 20mg Phase 1

Detailed Description:
An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/20 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 20 mg in Healthy Volunteers

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/20 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 20 mg in Healthy Volunteers
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HCP1201, Part 1
Participants received a single oral dose of the HCP1201 750/20mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).
Drug: HCP1201 750/20mg
750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Active Comparator: Metformin and Rosuvastatin, Part1
Participants received a single oral dose of coadministration of Metformin SR 750mg and Rosuvastatin 20mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).
Drug: Metformin SR 750mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
Other Name: Glucophage SR 750 mg

Drug: Rosuvastatin 20mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
Other Name: Crestor 20mg

Experimental: HCP1201, Part 2
Participants received a single oral dose of the HCP1201 750/20mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).
Drug: HCP1201 750/20mg
750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Active Comparator: Metformin and Rosuvastatin, Part 2
Participants received a single oral dose of coadministration of Metformin SR 750mg and Rosuvastatin 20mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).
Drug: Metformin SR 750mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
Other Name: Glucophage SR 750 mg

Drug: Rosuvastatin 20mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
Other Name: Crestor 20mg




Primary Outcome Measures :
  1. metformin, rosuvastatin Cmax [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h ]
  2. metformin, rosuvastatin AUClast [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h ]

Secondary Outcome Measures :
  1. Metformin, rosuvastatin Tmax [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h ]
  2. Metformin, rosuvastatin T1/2 [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h ]
  3. Metformin, rosuvastatin AUCinf [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h ]
  4. Metformin, rosuvastatin CL/F [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h ]
  5. Metformin, rosuvastatin Vd/F [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male volunteer, age 20~55 years
  2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
  3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

  1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  2. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
  3. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
  4. SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
  5. History of relevant drug allergies or clinically significant hypersensitivity reaction.
  6. History of drug abuse or positive drug screening.
  7. Participation in other drug studies within 60days prior to the drug administration.
  8. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
  9. Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
  10. Subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin.
  11. Intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial.
  12. Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
  13. Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
  14. Genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication.
  15. Clinically inappropriate laboratory test result.
  16. Clinically inappropriate electrocardiogram result.
  17. Subjects who judged ineligible by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929512


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: JaeWook Ko, MD, PhD Samsung Medical Center

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01929512    
Other Study ID Numbers: HM-MERO-103
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Metformin
Rosuvastatin Calcium
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors