Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension; Hyperlipidemia
Intervention: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg (Drug); Telmisartan 80mg and S-amlodipine 5mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Chong Kun Dang Pharmaceutical Official(s) and/or principal investigator(s): Min Soo Park, Ph. D, Principal Investigator, Affiliation: Severance Hospital
Summary
The purpose of this study is to investigate the effect of Atorvastatin on the
pharmacokinetic properties of Telmisartan/S-amlodipine
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClastIn the steady state Telmisartan 80mg and S-amlodipine 5mg Cmax
Secondary outcome: In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinfIn the steady state Telmisartan 80mg & S-amlodipine 5mg Tmax In the steady state Telmisartan 80mg & S-amlodipine 5mg T1/2 Number of Participants with Adverse Events
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Both.
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).
Locations and Contacts
Severance Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: April 2013
Last updated: July 31, 2013
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