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Single-dose, 2-way Crossover Open Study to Evaluate the Food Effect on the PK of HCP1201 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01901757
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: HCP1201, Fasted followed by fed Drug: HCP1201, Fed followed by fasted Phase 1

Detailed Description:
An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteers

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers
Study Start Date : June 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: HCP1201, Fasted followed by fed
HCP1201 dosing in the fasted state followed by fed dosing
Drug: HCP1201, Fasted followed by fed
There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.

Drug: HCP1201, Fed followed by fasted
There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.

Experimental: HCP1201, Fed followed by fasted
HCP1201 dosing in the fed state followed by fasted dosing
Drug: HCP1201, Fasted followed by fed
There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.

Drug: HCP1201, Fed followed by fasted
There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.




Primary Outcome Measures :
  1. Metformin, rosuvastatin Cmax, 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 ]


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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. Systolic Blood Pressure: lower than 90mmHg or higher than 150mmHg, Diastolic Blood Pressure: 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): NCT01901757


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Jung Ryul Kim, M.D. Samsung Medical Center

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01901757     History of Changes
Other Study ID Numbers: HM-MERO-102
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases