Clinical trial NCT02047175: CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)
Official title: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug-drug interaction of CKD-346(Telmisartan/S-Amlodipine, 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.

Eligibility criteria: 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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Primary outcomes:
measure: AUCt,ss of Telmisartan/S-Amlodipine
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
measure: Cmax,ss of Telmisartan/S-Amlodipine
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
measure: AUCt,ss of Rosuvastatin
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
measure: Cmax,ss of Rosuvastatin
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
Secondary outcomes:
measure: Tmax,ss of Telmisartan/S-Amlodipine
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
measure: T1/2 of Telmisartan/S-Amlodipine
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
measure: CL/F of Telmisartan/S-Amlodipine
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
measure: Vd/F of Telmisartan/S-Amlodipine
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
measure: R of Telmisartan/S-Amlodipine
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
measure: Tmax,ss of Rosuvastatin
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
measure: T1/2 of Rosuvastatin
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
measure: CL/F of Rosuvastatin
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
measure: Vd/F of Rosuvastatin
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
measure: R of Rosuvastatin
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The catholic university of Korea, seoul ST.Mary's hospital
state: Gangnam-gu
Study officials:
affiliation: The Catholic University of Korea
name: Dong-seok Yim, professor
role: PRINCIPAL_INVESTIGATOR
References: