HypertensionPhase 1NCT05223101
A Bioequivalence Study Between Telmione 80 mg and Micardis 80 mg in Healthy Adult Volunteers
A Phase 1 study testing Telminone 80 mg and Drug: Micardis 80 mg in people with Hypertension, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
To compare the pharmacokinetics and safety after a single dose administration of Telmione® 80 mg and Micardis® 80 mg 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?
- Telminone 80 mg and Drug: Micardis 80 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jan 2022to Jul 2022
- 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 (telmisartan) with IPs and excipients
- 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) ≥ 150 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, 1 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Min Kyu Park, MD, PhD, +82-43-269-8708, mk_park@cbnuhctc.com
About this study
Official title: A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of TELMI ONE TAB. 80 mg and MICARDIS TAB. 80 mg(Telmisartan) in Healthy Adult Volunteers
To compare the pharmacokinetics and safety after a single dose administration of Telmione® 80 mg and Micardis® 80 mg in healthy adult volunteers
- Conditions
- Hypertension
- Being tested
- Telminone 80 mg, Drug: Micardis 80 mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telminone 80 mgDrug
Single administration of telmisartan 80 mg
Drug: Micardis 80 mgDrug
Single administration of telmisartan 80 mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | TRTR Receives: Drug: Telminone 80 mg; Drug: Drug: Micardis 80 mg |
| Sequence B | Experimental | RTRT Receives: Drug: Telminone 80 mg; Drug: Drug: Micardis 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of telmisartan
Measured: Up to 72 hours
AUClast of telmisartan
Measured: Up to 72 hours
Secondary outcomes (5)
Tmax of telmisartan
Measured: Up to 72 hours
AUCinf of telmisartan
Measured: Up to 72 hours
t1/2 of telmisartan
Measured: Up to 72 hours
CL/F of telmisartan
Measured: Up to 72 hours
Vd/F of telmisartan
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.
- First posted3 Feb 2022
- Study start19 Jan 2022
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223101
- Sponsor's protocol ID
- IN_TMO_101
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of TELMI ONE TAB. 80 mg and MICARDIS TAB. 80 mg(Telmisartan) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05223101
- Acronym / sponsor ID
- IN_TMO_101
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the pharmacokinetics and safety after a single dose administration of Telmione® 80 mg and Micardis® 80 mg in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Telminone 80 mg, Drug: Drug: Micardis 80 mgTRTR |
| Sequence B | Experimental | Drug: Telminone 80 mg, Drug: Drug: Micardis 80 mgRTRT |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (28 listed)
- 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 (telmisartan) with IPs and excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telminone 80 mgSingle administration of telmisartan 80 mg | Drug | Sequence A, Sequence B |
| Drug: Micardis 80 mgSingle administration of telmisartan 80 mg | Drug | Sequence A, Sequence B |
Primary outcome
Cmax of telmisartan
Time frame: Up to 72 hours
AUClast of telmisartan
Time frame: Up to 72 hours
5 secondary outcomes
Tmax of telmisartan
Time frame: Up to 72 hours
AUCinf of telmisartan
Time frame: Up to 72 hours
t1/2 of telmisartan
Time frame: Up to 72 hours
CL/F of telmisartan
Time frame: Up to 72 hours
Vd/F of telmisartan
Time frame: Up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telminone 80 mg and Drug: Micardis 80 mg 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: status not confirmed, as of the sponsor's last update on 2 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heechan Lee, MS (+82-2-6477-0222, heechan.lee@inno-n.com), or a site near the patient. 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 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2022.