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Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992211
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
BC World Pharm Co. Ltd.

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to evaluate the food effect of Pharmacokinetic profile of BCWP_C003 after administration.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosuvastatin Drug: Metformin Drug: BCWP_C003 Phase 1

Detailed Description:
Clinical Trials to Evaluate the Pharmacokinetic Profiles and Safety/Tolerability of BCWP_C003 Formulation compared to Coadministration of Rosuvastatin and Metformin SR Formulation, and to Evaluate the Effect of Food on the Pharmacokinetic Profile of BCWP_C003 after Single Oral Administration to Healthy Male Subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 6 x 3
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized, Open, Cross-over, Single Dose Study to Evaluate the PK, Safety/Tolerability of BCWP_C003 Compared to Coadministration of Rosuvastatin and Metformin SR, and the Food Effect on the PK of BCWP_C003 in Healthy Volunteers
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : July 10, 2017


Arm Intervention/treatment
Experimental: Treatment Sequence 1(ABC)

Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day.

Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day.

Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day.

Drug: Rosuvastatin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Crestor 10mg(Rosuvastatin)

Drug: Metformin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Glucophage XR 1000mg(Metformin)

Drug: BCWP_C003
Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
Other Name: Rosuvastatin and Metformin

Experimental: Treatment Sequence 2(ACB)

Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day.

Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day.

Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day.

Drug: Rosuvastatin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Crestor 10mg(Rosuvastatin)

Drug: Metformin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Glucophage XR 1000mg(Metformin)

Drug: BCWP_C003
Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
Other Name: Rosuvastatin and Metformin

Experimental: Treatment Sequence 3(BAC)

Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day.

Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day.

Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day.

Drug: Rosuvastatin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Crestor 10mg(Rosuvastatin)

Drug: Metformin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Glucophage XR 1000mg(Metformin)

Drug: BCWP_C003
Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
Other Name: Rosuvastatin and Metformin

Experimental: Treatment Sequence 4(BCA)

Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day.

Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day.

Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day.

Drug: Rosuvastatin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Crestor 10mg(Rosuvastatin)

Drug: Metformin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Glucophage XR 1000mg(Metformin)

Drug: BCWP_C003
Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
Other Name: Rosuvastatin and Metformin

Experimental: Treatment Sequence 5(CAB)

Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day.

Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day.

Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day.

Drug: Rosuvastatin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Crestor 10mg(Rosuvastatin)

Drug: Metformin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Glucophage XR 1000mg(Metformin)

Drug: BCWP_C003
Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
Other Name: Rosuvastatin and Metformin

Experimental: Treatment Sequence 6(CBA)

Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day.

Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day.

Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day.

Drug: Rosuvastatin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Crestor 10mg(Rosuvastatin)

Drug: Metformin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Other Name: Glucophage XR 1000mg(Metformin)

Drug: BCWP_C003
Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
Other Name: Rosuvastatin and Metformin




Primary Outcome Measures :
  1. Rosuvastatin AUClast [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Rosuvastatin AUClast

  2. Rosuvastatin Cmax [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Rosuvastatin Cmax

  3. Metformin AUClast [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Metformin AUClast

  4. Metformin Cmax [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Metformin Cmax


Secondary Outcome Measures :
  1. N-desmethyl rosuvastatin Cmax [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    N-desmethyl rosuvastatin Cmax

  2. N-desmethyl rosuvastatin AUClast [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    N-desmethyl rosuvastatin AUClast

  3. N-desmethyl rosuvastatin AUCinf [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    N-desmethyl rosuvastatin AUCinf

  4. Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf

  5. Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax

  6. Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2 [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2

  7. Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F

  8. Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F [ Time Frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h ]
    Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Male Volunteer, age 19 to 45 years at the time of screening
  • Body weight is not less than 55kg, not more than 90kg and the result of Body Mass Index(BMI) is not less than 18.5, not more than 25.0
  • Subject who has no congenital, chronic disease, and no disease symptom or finding in medical examination result
  • Subject who comprehended the purpose, contents of the study, property of clinical drug and signed the informed consent to participate in the trial having the willingness

Exclusion Criteria:

  • Subject who has history of hypersensitivity reaction for relevant drug(statin, biguanide) or clinically significant hypersensitivity reaction
  • Subject who has history or presence of clinically disease in liver, kidney, gastrointestinal tract, respiratory system, musculoskeletal, endocrine system, mental disorder, blood-tumor, cardiovascular. Particulary, subject who has bleeding disorder or tend to be bleeding with bruised easily
  • Subject who has family history of hereditary muscular disorder or muscular side effect
  • Subject who has history of gastrointestinal tract disorder which can affect the drug absorption or surgery(excluding appendectomy, hernia surgery)
  • Subject who had taken diagnosis with peptic ulcer within 2 month prior to the drug administration
  • Subject who has results of clinical laboratory test as follows :

    • AST, ALT level exceed the normal range more than 1.5 times
    • Total bilirubin level exceed the normal range more than 1.5 times
    • Creatinine clearance under 60mL/min calculated by MDRD
  • In the vital sign, systolic blood pressure is more than 150mmHg, less than 90mmHg or diastolic blood pressure is more than 95mmHg, less than 50mmHg
  • Subject who has presence or history of drug abuse, or positive screening for drug abuse

    → Alcohol abuse defines to drink over 21 unit/week(alcohol 1unit = 10g = 12.5 mL) persistingly

  • Subject who participated in another clinical trial within 3 month prior to the drug administration
  • Subject who had taken medicine(Barbital etc) related drug metabolizing enzyme induction or inhibition within 1 month prior to the drug administration
  • Subject who had taken prescription drug or oriental medicine within 2 weeks or OTC drug or vitamin formulation within a week prior to the drug administration
  • Subject who had a diet which can affect the absorption, distribution, metabolism or elimination of Rosuvastatin/Metformin (Particulary, Grapefruit - within 48h prior to the drug administration)
  • Subject who donated whole blood within 2 month or component blood within 1 month prior to the drug administration
  • Subject who smokes more than 10 cigarettes per day
  • Subject who has positive HBsAg, HCV Ab or HIV Ab
  • Subject who is judged to be ineligible by principal investigator or sub-investigator according to various test results

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): NCT01992211


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
BC World Pharm Co. Ltd.
Investigators
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Principal Investigator: Kyung-Sang Yu, MD. PhD. Seoul National University Hospital
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Responsible Party: BC World Pharm Co. Ltd.
ClinicalTrials.gov Identifier: NCT01992211    
Other Study ID Numbers: BCWP1202_102
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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