Hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-536TCH
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material :
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. In the opinion of the investigator and subinvestigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3. The participant is a healthy Japanese adult male. 4. The participant is aged 20 to 35 years, inclusive at the time of informed consent. 5. The participant weighs at least 50.0 kg and has a body mass index (BMI) from 18.5 to 25.0 kg/m2, inclusive at Screening.
Exclusion criteria
Exclusion criteria: 1. Participant has systolic blood pressure 1.5-fold of the upper limits of normal range. 8. Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations and urinary excretion rates Primary timeframe: 5 days Pharmacokinetics of unchanged TAK-536 and its major metabolites (M-I and M-II), AML and HCTZ | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events (AE) Secondary timeframe: Up to 36 days The frequencies of all adverse events that occur after study drug administration will be tabulated. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. | — |
Outcome results
None listed