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

NCT ID: NCT01992211

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-15
• Study Completion Date: 2017-07-10

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

BCWP_C003

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

BCWP_C003

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

BCWP_C003

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

BCWP_C003

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

BCWP_C003

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

BCWP_C003

Intervention Type: DRUG

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

Interventions

Rosuvastatin

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

Intervention Type: DRUG

Metformin

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

Intervention Type: DRUG

BCWP_C003

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

Intervention Type: DRUG

Other Intervention Names

Crestor 10mg(Rosuvastatin); Glucophage XR 1000mg(Metformin); Rosuvastatin and Metformin

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

BC World Pharm Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Sang Yu, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BCWP1202_102

Identifier Type: -

Identifier Source: org_study_id