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A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation

A Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Healthy Adult Male Subjects

NCT03042299•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.

Detailed Description

The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.

Eligibility

Age

20 - 35 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
•2. Signs and dates a written, informed consent form prior to the initiation of any study procedures.
•3. Is a Japanese healthy adult male.
•4. Aged 20 to 35 years, inclusive, at the time of informed consent.
•5. Weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2), inclusive, at Screening.

Exclusion Criteria

•1. Has suspected hypotension with associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on the day before the study drug administration (Day -1) in Period 1, or up to the study drug administration on the Period 1.
•2. Has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.
•3. Has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
•4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
•5. Has a known hypersensitivity to any component of the formulation of TAK-536 or any angiotensin II receptor blocker (ARB).
•6. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.
•7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
•8. Has taken any excluded medication, supplements, dietary products, or food products during the time periods specified in the protocol.
•9. Has any current or recent (within 6 months) gastrointestinal diseases that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention).
•10. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1 of Period 1.
+8 more criteria

Locations (1)

Nishi Kumamoto Hospital

Kumamoto, Japan

Key Dates

Start Date

February 10, 2017

Primary Completion Date

March 11, 2017

Completion Date

March 11, 2017

Last Updated

November 14, 2018

Enrollment

ACTUAL participants

Conditions

Japanese Healthy Adult Male Participants

Interventions

TAK-536

DRUG

TAK-536

DRUG