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

NCT01992211 | Completed Phase 1 DMC

• 1 other identifier: BCWP1202_102
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

  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

  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

  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

  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

Study Arms (6)

Treatment Sequence 1(ABC)

EXPERIMENTAL

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; Drug: Metformin; Drug: BCWP_C003

Treatment Sequence 2(ACB)

EXPERIMENTAL

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; Drug: Metformin; Drug: BCWP_C003

Treatment Sequence 3(BAC)

EXPERIMENTAL

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; Drug: Metformin; Drug: BCWP_C003

Treatment Sequence 4(BCA)

EXPERIMENTAL

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; Drug: Metformin; Drug: BCWP_C003

Treatment Sequence 5(CAB)

EXPERIMENTAL

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; Drug: Metformin; Drug: BCWP_C003

Treatment Sequence 6(CBA)

EXPERIMENTAL

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; Drug: Metformin; Drug: BCWP_C003

Interventions

Rosuvastatin DRUG

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

Also known as: Crestor 10mg(Rosuvastatin)

Treatment Sequence 1(ABC); Treatment Sequence 2(ACB); Treatment Sequence 3(BAC); Treatment Sequence 4(BCA); Treatment Sequence 5(CAB); Treatment Sequence 6(CBA)

Metformin DRUG

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

Also known as: Glucophage XR 1000mg(Metformin)

Treatment Sequence 1(ABC); Treatment Sequence 2(ACB); Treatment Sequence 3(BAC); Treatment Sequence 4(BCA); Treatment Sequence 5(CAB); Treatment Sequence 6(CBA)

BCWP_C003 DRUG

Participant will be administered a single oral dose of BCWP\_C003 under Fasting condition or Fed condition according to sequence.

Also known as: Rosuvastatin and Metformin

Treatment Sequence 1(ABC); Treatment Sequence 2(ACB); Treatment Sequence 3(BAC); Treatment Sequence 4(BCA); Treatment Sequence 5(CAB); Treatment Sequence 6(CBA)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BC World Pharm Co. Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; Metformin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Kyung-Sang Yu, MD. PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 6 x 3

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: December 15, 2016
• Primary Completion: April 28, 2017
• Study Completion: July 10, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)