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HypertensionPhase 1NCT05040880

A Bioequivalence Study Between Telmione Plus 80/12.5mg and Micardis Plus 80/12.5 mg in Healthy Adult Volunteers

A Phase 1 study testing Telmione plus 80/12.5mg and Micardis plus 80/12.5mg in people with Hypertension, run by HK inno.N Corporation 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

To compare the pharmacokinetics and safety after a single dose administration of Telmione plus® 80/12.5mg and Micardis plus® 80/12.5mg in healthy adult volunteers Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Telmione plus 80/12.5mg and Micardis plus 80/12.5mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteSouth Korea
Study dates
8 Jul 2021to 31 Oct 2021
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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adult volunteers aged ≥ 19 years at screening
  • Body weight ≥ 50kg and Body mass index (BMI) in the range of 18.0 and 30.0 kg/㎡
  • Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings as a result of physical examination
  • Determined by the investigator to be eligible for study participation based on the results of screening tests (clinical laboratory tests, vital signs, physical examination, 12-lead ECG) conducted according to the IP characteristics
  • Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

Who cannot join

  • Subjects with a presence and a history of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, oncologic, genitourinary, cardiovascular, gastrointestinal, musculoskeletal disease
  • Pregnant(positive urine HCG) or breastfeeding women if female
  • Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Subjects with a presence and a history of surgery or gastrointestinal diseases which might significantly change absorption of medicines
  • Subjects with hypersensitivity or a history of clinically significant hyper sensitivity to ingredients with IPs, excipients, other drugs including sulfonamide and renin-angiotensin class
  • Subjects with the following results in clinical laboratory tests
Show all 28Show fewer
  • AST/ALT/ALP/γ-GTP/Bilirubin total > UNL (upper normal limit) × 2
  • Creatinine in plasma which is outside the accepted normal range or eGFR calculated by MDRD < 60 mL/min/1.73 ㎡
  • CK > UNL × 2
  • Subjects with a history of drug abuse or positive to drug abuse at urine drug screening test
  • Subjects with systolic blood pressure (SBP) ≥ 140 mmHg or ≤ 90 mmHg, diastolic blood pressure (DBP) ≥ 100 mmHg or ≤ 60 mmHg, or pulse rate (PR) ≤ 40 bpm or ≥ 100 bpm on vital signs measured in sitting position after taking a rest for at least 3 minutes during screening test
  • Subjects with clinically significant opinions including the following results in 12-lead ECG test during screening test
  • QTc > 450 ms
  • PR interval > 200 ms
  • QRS duration > 120 ms
  • Subjects who have an abnormal diet that can affect ADME of drugs or consume foods that can affect drug metabolism
  • Subjects who have taken any prescription drugs or herbal medicine within 2 weeks prior to the 1st IP administration, or any over-the-counter (OTC) drug, health functional food or vitamin preparation within 10 days to the 1st IP administration (However, can participate in the study if otherwise eligible in the judgment of the investigator)
  • Subjects who have taken the drug which can induce or inhibit drug metabolism enzyme within 1 month prior to the 1st IP administration
  • Subjects who have participated in any other clinical study or bioequivalnece study within 6 months prior to the 1st IP administration(However, the criterion for termination of participation in other clinical study or bioequivalence study is the last administration date, and the next day is counted as one day.)
  • Subjects who have donated whole blood within 2 months prior to the 1st IP administration or have donated blood components or received transfusion within 1 month prior to the 1st IP administration
  • Subject who have continued drink of alcohol (> 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the 1st IP administration or are unable to stop drinking from the time of signing the informed consent form to post study visit
  • alcohol (g) = intake volume(mL) × level(%) × 0.8
  • Subject who have a history of excessive smoking (> 10 cigarettes/day) within 3 months prior to the 1st IP administration and unable to stop smoking from 24 hours before the administration at each period to the last sampling time at each period
  • Subjects who take or are unable to stop foods containing grapefruit from 48 hours before the 1st IP administration to post study visit
  • Subject who take or are unable to stop foods containing caffeine(coffee, green tea, black tee, soda, coffee-flavored milk, nutritive tonic drink) from 24 hours before the administration at each period to the last sampling time at each period
  • Subjects who have exercised vigorously exceeding the level of daily life during the period from 48 hours before the 1st administration to post study visit, or who are unable to stop vigorous exercise
  • Subjects or their spouse or partner who are not using an approved method of contraception or even if are not planning to become pregnant (e.g., contraceptive administration and implantation, intrauterine device, Those who are not using procedures (vasectomy, tubal ligation, etc.) from the time of written consent of the subject until two weeks after the last bioequivalence study drug administration date
  • Subjects who have determined that the investigator is unsuitable to participate in the bioequivalence test due to reasons other than the above selection/exclusion criteria

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

Other trials in South Korea

About this study

Official title: A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of TELMIONE PLUS TAB. 80/12.5mg and MICARDIS PLUS TAB. 80/12.5mg in Healthy Adult Volunteers

To compare the pharmacokinetics and safety after a single dose administration of Telmione plus® 80/12.5mg and Micardis plus® 80/12.5mg in healthy adult volunteers

Conditions
Hypertension
Being tested
Telmione plus 80/12.5mg, Micardis plus 80/12.5mg
Medical subject headings
Hypertension

What participants receive

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

  • Telmione plus 80/12.5mgDrug

    Test drug (Fixed-dose combination drug of telmisartan 80mg and hydrochlorothiazide 12.5mg)

  • Micardis plus 80/12.5mgDrug

    Reference drug (Fixed-dose combination drug of telmisartan 80mg and hydrochlorothiazide 12.5mg)

Study groups in NCT05040880
Study groupRoleWhat they receive
Sequence AExperimentalTRTR
Receives: Drug: Telmione plus 80/12.5mg; Drug: Micardis plus 80/12.5mg
Sequence BExperimentalRTRT
Receives: Drug: Telmione plus 80/12.5mg; Drug: Micardis plus 80/12.5mg

What is being measured

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

  1. Cmax of telmisartan

    Measured: Up to 72 hours

  2. AUClast of telmisartan

    Measured: Up to 72 hours

  3. Cmax of hydrochlorothiazide

    Measured: Up to 72 hours

  4. AUClast of hydrochlorothiazide

    Measured: Up to 72 hours

Secondary outcomes (10)

  1. Tmax of telmisartan

    Measured: Up to 72 hours

  2. AUCinf of telmisartan

    Measured: Up to 72 hours

  3. t1/2 of telmisartan

    Measured: Up to 72 hours

  4. CL/F of telmisartan

    Measured: Up to 72 hours

  5. Vd/F of telmisartan

    Measured: Up to 72 hours

  6. Tmax of hydrochlorothiazide

    Measured: Up to 72 hours

  7. AUCinf of hydrochlorothiazide

    Measured: Up to 72 hours

  8. t1/2 of hydrochlorothiazide

    Measured: Up to 72 hours

  9. CL/F of hydrochlorothiazide

    Measured: Up to 72 hours

  10. Vd/F of hydrochlorothiazide

    Measured: Up to 72 hours

Timeline

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

  1. First posted10 Sep 2021
  2. Study start8 Jul 2021
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05040880
Sponsor's protocol ID
IN_TMP_101
Status last verified
Feb 2022
First submitted
25 Aug 2021
Last updated
16 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Telmione plus 80/12.5mg and Micardis plus 80/12.5mg in people with Hypertension, run by HK inno.N Corporation 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 5 inclusion and 28 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 16 Feb 2022. 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?

Cmax of telmisartan (time frame: Up to 72 hours). 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 NCT05040880.

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 16 Feb 2022.

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