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

BC World Pharm

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin; Drug: Rosuvastatin; Drug: BCWP_C003

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992211

BCWP1202_102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 6 patient groups

Treatment Sequence 1(ABC)

Experimental group

Description:

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.

Treatment:

Drug: BCWP_C003

Drug: Rosuvastatin

Drug: Metformin

Treatment Sequence 2(ACB)

Experimental group

Description:

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.

Treatment:

Drug: BCWP_C003

Drug: Rosuvastatin

Drug: Metformin

Treatment Sequence 3(BAC)

Experimental group

Description:

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.

Treatment:

Drug: BCWP_C003

Drug: Rosuvastatin

Drug: Metformin

Treatment Sequence 4(BCA)

Experimental group

Description:

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.

Treatment:

Drug: BCWP_C003

Drug: Rosuvastatin

Drug: Metformin

Treatment Sequence 5(CAB)

Experimental group

Description:

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.

Treatment:

Drug: BCWP_C003

Drug: Rosuvastatin

Drug: Metformin

Treatment Sequence 6(CBA)

Experimental group

Description:

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.

Treatment:

Drug: BCWP_C003

Drug: Rosuvastatin

Drug: Metformin