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

NCT01842256 | Completed Phase 1

• 1 other identifier: 142HPS13002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Essential Hypertension; Hyperlipidemia

Keywords

Telminouveau; Atorvastatin; Pharmacokinetic; Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• In the steady state atorvastatin 40mg AUClast

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

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose

• In the steady state atorvastatin 40mg Cmax

  Cmax: maximum plasma drug concentration

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose

Secondary Outcomes (9)

• 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

• 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

• 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

• Number of participants with adverse events

  From 1day to 17days

• 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

Study Arms (2)

Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg

EXPERIMENTAL

Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; Drug: atorvastatin 40mg

Atorvastatin 40mg

ACTIVE COMPARATOR

Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; Drug: atorvastatin 40mg

Interventions

Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg DRUG

* 3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one), * oral intake, once in a period * over the period Ⅰ\&Ⅱ(crossover)

Atorvastatin 40mg; Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg

atorvastatin 40mg DRUG

* 1 Tablet (atorvastatin 40mg), * oral intake, once in a period * over the period Ⅰ\&Ⅱ(crossover)

Atorvastatin 40mg; Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20 aged and 45 aged in healthy male and female
• Body weight more than 55kg in male, 50kg in female
• Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2)
• If female, must include more than one among the items
• The menopause (there is no natural menses for at least 2 years)
• Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
• The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject.
• 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)
• 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.
• 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
• 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.

You may not qualify if:

• 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.
• Have a gastrointestinal disease history that can affect drug absorption (Crohn, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)
• Hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin calcium) or additives
• 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.
• 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
• Sitting SBP \> 150 mmHg or \< 90 mmHg, Sitting DBP\> 100 mmHg or \< 50 mmHg , after 5minuts break.
• Drug abuse or have a history of drug abuse showed a positive for the Triage TOX drug on urine.
• Pregnant or lactating women.
• A heavy caffeine consumer(caffeine\>5cups/day), alcohol consumer(alcohol\>210g/week), or smoker(cigarette\>10cigarettes /day)
• 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.
• Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension; Hyperlipidemias

Interventions

Telmisartan; levamlodipine; Atorvastatin

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Min Soo Park, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 29, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

KR (1)