CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)

NCT02047175 | Completed Phase 1

• 1 other identifier: 147DDI13019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the drug-drug interaction of CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)

Conditions

Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (4)

• AUCt,ss of Telmisartan/S-Amlodipine

  0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

• Cmax,ss of Telmisartan/S-Amlodipine

  0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

• AUCt,ss of Rosuvastatin

  0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

• Cmax,ss of Rosuvastatin

  0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

Secondary Outcomes (10)

• Tmax,ss of Telmisartan/S-Amlodipine

  0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

• T1/2 of Telmisartan/S-Amlodipine

  0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

• CL/F of Telmisartan/S-Amlodipine

  0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

• Vd/F of Telmisartan/S-Amlodipine

  0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

• R of Telmisartan/S-Amlodipine

  0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

Study Arms (2)

A(Telmisartan/S-Amlodipine)

EXPERIMENTAL

A(Telmisartan/S-Amlodipine) : Telmisartan/S-Amlodipine 40/2.5mg 2T for 9days and Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T for 5days

Drug: Telmisartan/S-Amlodipine; Drug: Telmisartan/S-Amlodipine + Rosuvastatin

B(Rosuvastatin)

EXPERIMENTAL

B(Rosuvastatin) : Rosuvastatin 20mg 1T for 5days and Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T for 9days

Drug: Rosuvastatin; Drug: Telmisartan/S-Amlodipine + Rosuvastatin

Interventions

Telmisartan/S-Amlodipine DRUG

Telmisartan/S-Amlodipine 40/2.5mg 2T PO, QD for 9days

Also known as: Telminuvo tablet

A(Telmisartan/S-Amlodipine)

Rosuvastatin DRUG

Rosuvastatin 20mg 1T PO, QD for 5days

Also known as: Crestor tablet

B(Rosuvastatin)

Telmisartan/S-Amlodipine + Rosuvastatin DRUG

Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days

Also known as: Telminuvo tablet + Crestor tablet

A(Telmisartan/S-Amlodipine)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is a male or female between 20 and 45 years of age (inclusive) at the pre-study (screening)
• Participant who has a body weight that is \>55kg(male) or \>50kg(female) with ideal body weight of 80-120% (ideal body weight) = {Height(cm) - 100} \* 0.9
• If female, must include more than one among the items
• The menopause (there is no natural menses for at least 2 years)
• Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
• The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject.
• you are using one of the following contraceptive measure for 3 months before screening, and Necessarily you agree that used continuously contraceptive measure during the clinical trial and for 1 month after the final dosing investigational product.(But, should not use a device of contraception or oral contraceptive drug that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium drug interactions during the clinical trials)
• Abstinence.
• Physical interrupt method (such as a condom, contraceptive diaphoretic or cervical cap)
• In case of women of childbearing age, the serum β-hCG pregnancy test is negative before taking the investigational product, and urine β-hCG test is negative before taking the investigational product.
• If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms during clinical trials and do not sperm donation during clinical trials and until one month after the final dosage of investigational products
• Those who fully understand about this clinical trial after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent.

You may not qualify if:

• The subject has a previous history of any clinically significant cardiovascular, pulmonary, renal, endocrine, hematological, gastro-intestinal, neurological, psychiatric, or malignancy.
• Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery).
• Hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or rosuvastatin calcium) or additives.
• An impossible one who participates in clinical trial including screening tests(medical history taking, V/S, physical examination, 12-lead ECG, blood \& urine laboratory test result)
• Defined by the following laboratory parameters:
• Hemoglobin \< 13.0 g/dL(male), Hemoglobin \< 12.0 g/dL(female)
• AST, ALT\> 1.25\* upper limit of normal range
• Total bilirubin \> 1.5\* upper limit of normal range
• CPK \> 1.5\* upper limit of normal range
• eGFR(using by MDRD method) \< 60 mL/min/1.73m2
• Sitting SBP \> 150 mmHg or \< 90 mmHg, Sitting DBP\> 100 mmHg or \< 50 mmHg , after 5minuts break.
• Drug abuse or have a history of drug abuse showed a positive for urine drug test.
• Female Participant is pregnant or lactating
• A heavy caffeine consumer(caffeine\>5cups/day), alcohol consumer(alcohol\>210g/week), or smoker(cigarette\>10cigarettes/day)
• Participation in any other study and have received any other investigational drug or device within 90 days prior to study treatment.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

The catholic university of Korea, seoul ST.Mary's hospital

Seoul, Gangnam-gu, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dong-seok Yim, professor

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

KR (1)