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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Metformin; Drug: BCWP_C003

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Rosuvastatin and Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rosuvastatin AUClast	Rosuvastatin AUClast	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	Rosuvastatin Cmax	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	Metformin AUClast	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	Metformin Cmax	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N-desmethyl rosuvastatin Cmax	N-desmethyl rosuvastatin Cmax	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	N-desmethyl rosuvastatin AUClast	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	N-desmethyl rosuvastatin AUCinf	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	Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf	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	Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax	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	Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2	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	Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F	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	Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F	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

Collaborators and Investigators

• Sponsor: BC World Pharm Co. Ltd.
• Investigators: Principal Investigator: Kyung-Sang Yu, MD. PhD., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Metformin
• Other Study ID Numbers: BCWP1202_102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No