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Trial record 93 of 914 for:    tablet | Japan

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

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ClinicalTrials.gov Identifier: NCT03042299
Recruitment Status : Completed
First Posted : February 3, 2017
Results First Posted : October 8, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief 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.

Condition or disease Intervention/treatment Phase
Japanese Healthy Adult Male Participants Drug: TAK-536 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : March 11, 2017
Actual Study Completion Date : March 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAK-536 Granules + TAK-536 Tablet
TAK-536 10 milligram (mg), granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
Drug: TAK-536
TAK-536 granules.

Drug: TAK-536
TAK-536 tablet.

Experimental: TAK-536 Tablet + TAK-536 Granules
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
Drug: TAK-536
TAK-536 granules.

Drug: TAK-536
TAK-536 tablet.




Primary Outcome Measures :
  1. AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536 [ Time Frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) ]
  2. Cmax: Maximum Observed Plasma Concentration for TAK-536 [ Time Frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) ]

Secondary Outcome Measures :
  1. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 [ Time Frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) ]
  2. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 [ Time Frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) ]
  3. MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536 [ Time Frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) ]
  4. Terminal Disposition Phase Rate Constant (λz) for TAK-536 [ Time Frame: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours) ]
  5. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18) ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

  6. Number of Participants With TEAEs Related to Vital Signs [ Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18) ]
  7. Number of Participants With TEAEs Related to Body Weight [ Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18) ]
  8. Number of Participants With TEAEs Related to Electrocardiograms (ECGs) [ Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18) ]
  9. Number of Participants With TEAEs Related to Clinical Laboratory Tests [ Time Frame: Baseline up to Day 6 of Intervention Period 2 (Day 18) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.
  11. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at Screening.
  12. Has poor peripheral venous access.
  13. Has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study drug administration in Period 1.
  14. Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of the study drug administration in Period 1.
  15. Has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1.
  16. Has an abnormal (clinically significant) ECG at Screening or prior to the study drug administration in Period 1.
  17. Has abnormal laboratory values that suggest a clinically significant underlying disease, or participant with the following laboratory abnormalities at Screening or prior to the study drug administration in Period 1: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>) 1.5 * the upper limits of normal (ULN).
  18. Who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042299


Locations
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Japan
Nishi Kumamoto Hospital
Kumamoto, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] December 22, 2016
Statistical Analysis Plan  [PDF] May 18, 2017


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03042299     History of Changes
Other Study ID Numbers: Azilsartan-1004
U1111-1190-0845 ( Registry Identifier: WHO )
JapicCTI-173503 ( Registry Identifier: JapicCTI )
First Posted: February 3, 2017    Key Record Dates
Results First Posted: October 8, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
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Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action