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

A Randomized, Open-label, Multiple-dose, Two-arm, One-sequence • Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration Telmisartan/S-amlodipine and Rosuvastatin in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Drug: Telmisartan/S-Amlodipine; Drug: Telmisartan/S-Amlodipine + Rosuvastatin; Drug: Telmisartan/S-Amlodipine + Rosuvastatin; Drug: Rosuvastatin

Detailed Description

A randomized, open-label, multiple-dose, two-arm, one-sequence · crossover study to evaluate the safety and pharmacokinetics after oral concurrent administration telmisartan/s-amlodipine and rosuvastatin in healthy volunteers.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of
      • The Catholic University of Korea, Seoul St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant is a male or female between 20 and 45 years of age (inclusive) at the pre-study (screening)
2. 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

3. If female, must include more than one among the items

   1. The menopause (there is no natural menses for at least 2 years)
   2. Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
   3. The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject.

   4. 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)
   5. 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.
4. 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
5. 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.

Exclusion Criteria:

1. The subject has a previous history of any clinically significant cardiovascular, pulmonary, renal, endocrine, hematological, gastro-intestinal, neurological, psychiatric, or malignancy.
2. Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery).
3. Hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or rosuvastatin calcium) or additives.
4. 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)

5. 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
6. Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after 5minuts break.
7. Drug abuse or have a history of drug abuse showed a positive for urine drug test.
8. Female Participant is pregnant or lactating
9. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes/day)
10. Participation in any other study and have received any other investigational drug or device within 90 days prior to study treatment.
11. Administration of drug metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
12. Blood donation (1 unit or more) within 60 days prior to study treatment or plasma donation within 30 days prior to study treatment.
13. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
14. Subject takes ethical drug or herbal medicine within 14days, OTC or vitamins within 7days before the beginning of study treatment.

15. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A(Telmisartan/S-Amlodipine); 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; Telmisartan/S-Amlodipine 40/2.5mg 2T PO, QD for 9days; Other Names: Telminuvo tablet; Drug: Telmisartan/S-Amlodipine + Rosuvastatin; Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days; Other Names: Telminuvo tablet + Crestor tablet; Drug: Telmisartan/S-Amlodipine + Rosuvastatin; Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 9days; Other Names: Telminuvo tablet + Crestor tablet
Experimental: B(Rosuvastatin); B(Rosuvastatin) : Rosuvastatin 20mg 1T for 5days and Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T for 9days	Drug: Telmisartan/S-Amlodipine + Rosuvastatin; Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days; Other Names: Telminuvo tablet + Crestor tablet; Drug: Telmisartan/S-Amlodipine + Rosuvastatin; Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 9days; Other Names: Telminuvo tablet + Crestor tablet; Drug: Rosuvastatin; Rosuvastatin 20mg 1T PO, QD for 5days; Other Names: Crestor tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Tmax,ss of Rosuvastatin	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
T1/2 of Rosuvastatin	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
CL/F of Rosuvastatin	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
Vd/F of Rosuvastatin	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
R of Rosuvastatin	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Dong-seok Yim, professor, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 24, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Vitamins; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Vitamin B Complex; Amlodipine; Rosuvastatin Calcium; Niacin; Telmisartan
• Other Study ID Numbers: 147DDI13019