Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan 80mg; Drug: Chlorthalidone 25mg

• Registration Number: NCT01806363
• Lead Sponsor: HanAll BioPharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-07
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Telmisartan, Chlorthalidone + Telmisartan	Telmisartan 80mg	telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
Part A: Telmisartan, Chlorthalidone + Telmisartan	Chlorthalidone 25mg	telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
Part B: Chlorthalidone, Chlorthalidone + Telmisartan	Telmisartan 80mg	telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
Part B: Chlorthalidone, Chlorthalidone + Telmisartan	Chlorthalidone 25mg	telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally

Primary Outcome Measures

Name	Time	Method
Part A : AUC, Cmax of Telmisartan	Over a 24-hour sampling period
Part B : AUC, Cmax of Chlorthalidone	Over a 24-hour sampling period

Secondary Outcome Measures

Name	Time	Method
Part A : Cmin, tmax, CL/F of Telmisartan	Over a 24-hour sampling period
Part B : Cmin, tmax, CL/F of Chlorthalidone	Over a 24-hour sampling period

Trial Locations

Locations (1)

Kyungpook national university hospital Clionical center; 🇰🇷 Daegu, Gyeongsangbuk-do, Korea, Republic of