Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine

Hyperlipidemia Clinical Trial

— CKD-345 DDI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842230
• Other study ID #: 142HPS13001
• Status: Completed
• Phase: Phase 1
• First received: April 25, 2013
• Last updated: July 31, 2013
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 ß-hCG pregnancy test is negative, and urine ß-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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

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)
• Telmisartan 80mg and S-amlodipine 5mg
Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day over the period I & II(cross-over)

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClast	AUClast = Area under the plasma concentration-time curve from zero time until the last measurable concentration	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	No
Primary	In the steady state Telmisartan 80mg and S-amlodipine 5mg Cmax	Cmax=Maximum Plasma Drug Concentration	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	No
Secondary	In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinf	AUCinf=Area under the plasma concentration-time curve from time zero to infinity	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	No
Secondary	In the steady state Telmisartan 80mg & S-amlodipine 5mg Tmax	Tmax=Time to Cmax	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	No
Secondary	In the steady state Telmisartan 80mg & S-amlodipine 5mg T1/2	T1/2=Observed terminal elimination half-life	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	No
Secondary	Number of Participants with Adverse Events	Evaluated safety parameters included: Physical examination, vital sign, Laboratory test, ECG; Adverse event monitoring	From 1day to 22 days	Yes