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HypertensionPhase 1NCT02047175

CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)

A Phase 1 study testing Telmisartan/S-Amlodipine, Rosuvastatin and Telmisartan/S-Amlodipine + Rosuvastatin in people with Hypertension and Hyperlipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the drug-drug interaction of CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin) Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension, Hyperlipidemia
What is being tested?
Telmisartan/S-Amlodipine, Rosuvastatin and Telmisartan/S-Amlodipine + Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSouth Korea
Study dates
Feb 2014to Mar 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant is a male or female between 20 and 45 years of age (inclusive) at the pre-study (screening)
  • Participant who has a body weight that is >55kg(male) or >50kg(female) with ideal body weight of 80-120% (ideal body weight) = {Height(cm) - 100} * 0.9
  • 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.
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  • 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 before taking the investigational product, 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.

Who cannot join

  • The subject has a previous history of any clinically significant cardiovascular, pulmonary, renal, endocrine, hematological, gastro-intestinal, neurological, psychiatric, or malignancy.
  • Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease, 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 rosuvastatin calcium) or additives.
  • An impossible one who participates in clinical trial including screening tests(medical history taking, V/S, physical examination, 12-lead ECG, blood \& urine laboratory test result)
  • Defined by the following laboratory parameters:
  • Hemoglobin < 13.0 g/dL(male), Hemoglobin < 12.0 g/dL(female)
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  • 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 urine drug test.
  • Female Participant is pregnant or lactating
  • A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes/day)
  • Participation in any other study and have received any other investigational drug or device within 90 days prior to study treatment.
  • Administration of drug metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
  • Blood donation (1 unit or more) within 60 days prior to study treatment or plasma donation within 30 days prior to study treatment.
  • 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)
  • Subject takes ethical drug or herbal medicine within 14days, OTC or vitamins within 7days before the beginning of study treatment.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • -

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The catholic university of Korea, seoul ST.Mary's hospital

    Seoul, Gangnam-gu

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, Two-arm, One-sequence • Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration Telmisartan/S-amlodipine and Rosuvastatin in Healthy Volunteers

The purpose of this study is to evaluate the drug-drug interaction of CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)

Read the detailed description

A randomized, open-label, multiple-dose, two-arm, one-sequence · crossover study to evaluate the safety and pharmacokinetics after oral concurrent administration telmisartan/s-amlodipine and rosuvastatin in healthy volunteers.

Being tested
Telmisartan/S-Amlodipine, Rosuvastatin, Telmisartan/S-Amlodipine + Rosuvastatin
Medical subject headings
Hypertension, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telmisartan/S-AmlodipineDrug

    Also called Telminuvo tablet

    Telmisartan/S-Amlodipine 40/2.5mg 2T PO, QD for 9days

  • RosuvastatinDrug

    Also called Crestor tablet

    Rosuvastatin 20mg 1T PO, QD for 5days

  • Telmisartan/S-Amlodipine + RosuvastatinDrug

    Also called Telminuvo tablet + Crestor tablet

    Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days

  • Telmisartan/S-Amlodipine + RosuvastatinDrug

    Also called Telminuvo tablet + Crestor tablet

    Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 9days

Study groups in NCT02047175
Study groupRoleWhat they receive
A(Telmisartan/S-Amlodipine)ExperimentalA(Telmisartan/S-Amlodipine) : Telmisartan/S-Amlodipine 40/2.5mg 2T for 9days and Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T for 5days
Receives: Drug: Telmisartan/S-Amlodipine; Drug: Telmisartan/S-Amlodipine + Rosuvastatin
B(Rosuvastatin)ExperimentalB(Rosuvastatin) : Rosuvastatin 20mg 1T for 5days and Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T for 9days
Receives: Drug: Rosuvastatin; Drug: Telmisartan/S-Amlodipine + Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCt,ss of Telmisartan/S-Amlodipine

    Measured: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

  2. Cmax,ss of Telmisartan/S-Amlodipine

    Measured: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

  3. AUCt,ss of Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

  4. Cmax,ss of Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

Secondary outcomes (10)

  1. Tmax,ss of Telmisartan/S-Amlodipine

    Measured: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

  2. T1/2 of Telmisartan/S-Amlodipine

    Measured: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

  3. CL/F of Telmisartan/S-Amlodipine

    Measured: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

  4. Vd/F of Telmisartan/S-Amlodipine

    Measured: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

  5. R of Telmisartan/S-Amlodipine

    Measured: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h

  6. Tmax,ss of Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

  7. T1/2 of Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

  8. CL/F of Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

  9. Vd/F of Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

  10. R of Rosuvastatin

    Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02047175
Sponsor's protocol ID
147DDI13019
Status last verified
Apr 2014
First submitted
24 Jan 2014
Last updated
17 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Telmisartan/S-Amlodipine, Rosuvastatin and Telmisartan/S-Amlodipine + Rosuvastatin in people with Hypertension and Hyperlipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCt,ss of Telmisartan/S-Amlodipine (time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02047175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.

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