CKD-345: Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin.

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01842256
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the pharmacokinetic properties of atorvastatin.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension; Hyperlipidemia	Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; Drug: atorvastatin 40mg	Phase 1

Detailed Description

healthy subjects are administrated single-dose over the period Ⅰand Ⅱ(Crossover) of telmisartan/s-amlodipine, atorvastatin and atorvastatin.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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 Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin After Oral Administration in Healthy Volunteers
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg	Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; 3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one), oral intake, once in a period over the period Ⅰ&Ⅱ(crossover); Drug: atorvastatin 40mg; 1 Tablet (atorvastatin 40mg), oral intake, once in a period over the period Ⅰ&Ⅱ(crossover)
Active Comparator: Atorvastatin 40mg	Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; 3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one), oral intake, once in a period over the period Ⅰ&Ⅱ(crossover); Drug: atorvastatin 40mg; 1 Tablet (atorvastatin 40mg), oral intake, once in a period over the period Ⅰ&Ⅱ(crossover)

Outcome Measures

Primary Outcome Measures

1. In the steady state atorvastatin 40mg AUClast [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   AUClast: Area under the plasma concentration time curve from zero time until the last measurable concentration.

2. In the steady state atorvastatin 40mg Cmax [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   Cmax: maximum plasma drug concentration

Secondary Outcome Measures

1. In the steady state atorvastatin 40mg AUCinf [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   AUCinf: Area Under the Concentration time curve from time zero to infinity

2. In the steady state atorvastatin 40mg Tmax [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   Tmax: Time to Cmax

3. In the steady state atorvastatin 40mg t1/2 [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   t1/2: Observed terminal elimination half-life

4. Number of participants with adverse events [From 1day to 17days]

   Evaluated safety parameters included: physical examination, vital sign, laboratory test, ECG Adverse event monitoring

5. In the steady state Orthohydroxy-atorvastatin AUClast [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   AUClast: Area under the plasma concentration time curve from zero time until the last measurable concentration.

6. In the steady state Orthohydroxy-atorvastatin Cmax [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   Cmax: maximum plasma drug concentration

7. In the steady state Orthohydroxy-atorvastatin AUCinf [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   AUCinf: Area Under the Concentration time curve from time zero to infinity

8. In the steady state Orthohydroxy-atorvastatin Tmax [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   Tmax: Time to Cmax

9. In the steady state Orthohydroxy-atorvastatin t1/2 [0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose]

   t1/2: Observed terminal elimination half-life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

5. The menopause (there is no natural menses for at least 2 years)

6. Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)

7. The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject.

8. 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)

1. 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.

2. 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

3. 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, 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) within 28 days before the beginning of study treatment.

5. Defined by the following laboratory parameters:

• 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

1. Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after 5minuts break.

2. Drug abuse or have a history of drug abuse showed a positive for the Triage TOX drug on urine.

3. Pregnant or lactating women.

4. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes /day)

5. 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.

6. Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.

7. 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)

8. 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.

9. Previously donate whole blood within 60 days or component blood within 30days.

10. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

11. Positive for Hepatitis B, Hepatitis C, HIV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Min Soo Park, Ph.D, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT01842256
• Other Study ID Numbers: 142HPS13002
• First Posted: Apr 29, 2013
• Last Update Posted: Aug 1, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Chong Kun Dang Pharmaceutical: Telminouveau; Atorvastatin; Pharmacokinetic; Healthy volunteers
• Additional relevant MeSH terms: Essential Hypertension; Hyperlipidemias; Amlodipine; Telmisartan; Atorvastatin

Study Results

No Results Posted as of Aug 1, 2013