Clinical trial NCT01992211: Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: BC World Pharm Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 35
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 6 x 3
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rosuvastatin AUClast
timeFrame: 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
measure: Rosuvastatin Cmax
timeFrame: 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
measure: Metformin AUClast
timeFrame: 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
measure: Metformin Cmax
timeFrame: 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:
measure: N-desmethyl rosuvastatin Cmax
timeFrame: 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
measure: N-desmethyl rosuvastatin AUClast
timeFrame: 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
measure: N-desmethyl rosuvastatin AUCinf
timeFrame: 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
measure: Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf
timeFrame: 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
measure: Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax
timeFrame: 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
measure: Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2
timeFrame: 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
measure: Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F
timeFrame: 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
measure: Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: