Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

HanAll Biopharma

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Chlorthalidone 25mg; Drug: Telmisartan 80mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806363

HTECHL12I_1

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Part A: Telmisartan, Chlorthalidone + Telmisartan

Active Comparator group

Description:

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

Treatment:

Drug: Telmisartan 80mg

Drug: Chlorthalidone 25mg

Part B: Chlorthalidone, Chlorthalidone + Telmisartan

Active Comparator group

Description:

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

Treatment:

Drug: Telmisartan 80mg

Drug: Chlorthalidone 25mg