Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

NCT ID: NCT01806363

Last Updated: 2014-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-06-30

Brief Summary

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Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Telmisartan, Chlorthalidone + Telmisartan

telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally

Group Type ACTIVE_COMPARATOR

Telmisartan 80mg

Intervention Type DRUG

Chlorthalidone 25mg

Intervention Type DRUG

Part B: Chlorthalidone, Chlorthalidone + Telmisartan

telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally

Group Type ACTIVE_COMPARATOR

Telmisartan 80mg

Intervention Type DRUG

Chlorthalidone 25mg

Intervention Type DRUG

Interventions

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Telmisartan 80mg

Intervention Type DRUG

Chlorthalidone 25mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subjects
2. Age(yr)between 20 and 50
3. Signed written informed consent

Exclusion Criteria

1. Known hypersensitivity to investigator product, thiazide, sulphonamide and other drugs or additive.
2. History of any siginificant Sickness, Cardiovascular, Respiratory, Renal, Endocrine, Neurological, Psychic, Cancer, Gasstrointestinal, Hematologic.
3. History of drug and/or alcohol abuse
4. Over 10 tobaccos a day
5. Other condition which in the opinion of the investigator preclude enrollment into the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HanAll BioPharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Ran Yoon, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER

Locations

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Kyungpook national university hospital Clionical center

Daegu, Gyeongsangbuk-do, South Korea

Site Status

Countries

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South Korea

References

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Seong SJ, Lim MS, Lee J, Ohk B, Gwon MR, Kim BK, Kim HJ, Yang DH, Lee HW, Kang WY, Yoon YR. Evaluation of a Pharmacokinetic Interaction between Telmisartan and Chlorthalidone in Healthy Male Adult Subjects. Clin Drug Investig. 2016 Aug;36(8):613-23. doi: 10.1007/s40261-016-0406-y.

Reference Type DERIVED
PMID: 27206575 (View on PubMed)

Other Identifiers

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HTECHL12I_1

Identifier Type: -

Identifier Source: org_study_id

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