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

NCT05040880 | Completed Phase 1

• 1 other identifier: IN_TMP_101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

• Cmax of telmisartan

  Up to 72 hours

• AUClast of telmisartan

  Up to 72 hours

• Cmax of hydrochlorothiazide

  Up to 72 hours

• AUClast of hydrochlorothiazide

  Up to 72 hours

Secondary Outcomes (10)

• Tmax of telmisartan

  Up to 72 hours

• AUCinf of telmisartan

  Up to 72 hours

• t1/2 of telmisartan

  Up to 72 hours

• CL/F of telmisartan

  Up to 72 hours

• Vd/F of telmisartan

  Up to 72 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

TRTR

Drug: Telmione plus 80/12.5mg; Drug: Micardis plus 80/12.5mg

Sequence B

EXPERIMENTAL

RTRT

Drug: Telmione plus 80/12.5mg; Drug: Micardis plus 80/12.5mg

Interventions

Telmione plus 80/12.5mg DRUG

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

Sequence A; Sequence B

Micardis plus 80/12.5mg DRUG

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

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular 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

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: August 25, 2021
• First Posted: September 10, 2021
• Study Start: July 8, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

KR (1)