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

April 25, 2013
July 31, 2013
April 2013
May 2013   (final data collection date for primary outcome measure)
  • 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
  • In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClast [ Time Frame: Telmisartan: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:0, 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: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:0, 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
Complete list of historical versions of study NCT01842230 on ClinicalTrials.gov Archive Site
  • 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
  • In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinf [ Time Frame: Telmisartan: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:0, 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: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:0, 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: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:0, 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
Not Provided
Not Provided
 
Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Essential Hypertension
  • Hyperlipidemia
  • 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)
  • Experimental: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
    Interventions:
    • Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
    • Drug: Telmisartan 80mg and S-amlodipine 5mg
  • Active Comparator: Telmisartan 80mg and S-amlodipine 5mg
    Interventions:
    • Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
    • Drug: Telmisartan 80mg and S-amlodipine 5mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2013
May 2013   (final data collection date for primary outcome measure)

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).
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01842230
142HPS13001
No
Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
Not Provided
Principal Investigator: Min Soo Park, Ph. D Severance Hospital
Chong Kun Dang Pharmaceutical
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP