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A Bioequivalence Study Between Telmione 80 mg and Micardis 80 mg in Healthy Adult Volunteers | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT05223101•HK inno.N Corporation

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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
•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
+17 more criteria

Locations (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Key Dates

Start Date

January 19, 2022

Primary Completion Date

July 1, 2022

Completion Date

July 1, 2022

Last Updated

March 2, 2022

Enrollment

ESTIMATED participants

Conditions

Hypertension

Interventions

Telminone 80 mg

DRUG

Drug: Micardis 80 mg

DRUG

Contacts

Heechan Lee, MS

CONTACT

+82-2-6477-0222 heechan.lee@inno-n.com

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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