Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine (CKD-345 DDI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01842230
First received: April 25, 2013
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic properties of Telmisartan/S-amlodipine


Condition Intervention Phase
Essential Hypertension
Hyperlipidemia
Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
Drug: Telmisartan 80mg and S-amlodipine 5mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine After Oral Administration in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClast [ Time Frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose ] [ Designated as safety issue: No ]
    AUClast = Area under the plasma concentration-time curve from zero time until the last measurable concentration

  • In the steady state Telmisartan 80mg and S-amlodipine 5mg Cmax [ Time Frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine: Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose ] [ Designated as safety issue: No ]
    Cmax=Maximum Plasma Drug Concentration


Secondary Outcome Measures:
  • In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinf [ Time Frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose ] [ Designated as safety issue: No ]
    AUCinf=Area under the plasma concentration-time curve from time zero to infinity

  • In the steady state Telmisartan 80mg & S-amlodipine 5mg Tmax [ Time Frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose ] [ Designated as safety issue: No ]
    Tmax=Time to Cmax

  • In the steady state Telmisartan 80mg & S-amlodipine 5mg T1/2 [ Time Frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose ] [ Designated as safety issue: No ]
    T1/2=Observed terminal elimination half-life

  • Number of Participants with Adverse Events [ Time Frame: From 1day to 22 days ] [ Designated as safety issue: Yes ]
    • Evaluated safety parameters included: Physical examination, vital sign, Laboratory test, ECG
    • Adverse event monitoring


Enrollment: 24
Study Start Date: April 2013
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
  • Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
  • Atorvastatin 40mg: 1 tablet, oral, once daily, 2days
  • over the period I & II(cross-over)
Drug: Telmisartan 80mg and S-amlodipine 5mg
  • Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
  • over the period I & II(cross-over)
Active Comparator: Telmisartan 80mg and S-amlodipine 5mg Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
  • Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
  • Atorvastatin 40mg: 1 tablet, oral, once daily, 2days
  • over the period I & II(cross-over)
Drug: Telmisartan 80mg and S-amlodipine 5mg
  • Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
  • over the period I & II(cross-over)

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Between 20 aged and 45 aged in healthy male and female
  2. Body weight more than 55kg in male, 50kg in female
  3. Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2) 4.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, and urine β-hCG test is negative before taking the investigational product.

5.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 6.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. Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system (heart failure, etc.).or mental illness, or a history of mental disease.
  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 atorvastatin calcium) or additives.
  4. An impossible one who participates in clinical trial including screening tests(medical history taking, BP, physical examination, 12-lead ECG, blood & urine laboratory test result) before 28 days the taking Investigational Products.
  5. Defined by the following laboratory parameters:

    1. AST, ALT> 1.25* upper limit of normal range
    2. Total bilirubin > 1.5* upper limit of normal range
    3. CPK > 1.5* upper limit of normal range
    4. 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. Pregnant or lactating women.
  9. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes/day)
  10. Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of the subjects.
  11. Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
  12. 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)
  13. Subject who treated with any investigational drugs within 60days before the beginning of study treatment (However, biologicals applies for 90 days, but can be based on a more extended period of time by considering the half-life)
  14. Previously donate whole blood within 60 days or component blood within 30days.
  15. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  16. Positive for Serology test(Hepatitis B, Hepatitis C, HIV).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842230

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Min Soo Park, Ph. D Severance Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01842230     History of Changes
Other Study ID Numbers: 142HPS13001
Study First Received: April 25, 2013
Last Updated: July 31, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Telminuvo
Telmisartan
S-amlodipine
Atorvastatin
pharmacokinetics
Healthy volunteers

Additional relevant MeSH terms:
Hypertension
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Telmisartan
Amlodipine
Atorvastatin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 18, 2014