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Trial record 71 of 1130 for:    tablet | Japan

A Bioequivalence Study of TAK-536 Pediatric Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401464
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE March 24, 2015
First Posted Date  ICMJE March 27, 2015
Results First Submitted Date  ICMJE May 25, 2016
Results First Posted Date  ICMJE July 6, 2016
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort [ Time Frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose ]
  • Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort [ Time Frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose ]
  • AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort [ Time Frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose ]
  • Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort [ Time Frame: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
  • Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for unchanged TAK-536 [ Time Frame: Up to 48 hours ]
    AUC(0-48) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 48 hours in this study).
  • Maximum Observed Plasma Concentration for unchanged TAK-536 [ Time Frame: Up to 48 hours ]
    Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 6 of Intervention Period 2 ]
  • Number of Participants With TEAEs Related to Vital Signs [ Time Frame: Baseline up to Day 6 of Intervention Period 2 ]
  • Number of Participants With TEAEs Related to Body Weight [ Time Frame: Baseline up to Day 6 of Intervention Period 2 ]
  • Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) [ Time Frame: Baseline up to Day 6 of Intervention Period 2 ]
  • Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values [ Time Frame: Baseline up to Day 6 of Intervention Period 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
Number of participants who experience at least 1 treatment-emergent adverse event [ Time Frame: Up to 6 Days ]
An Adverse Event 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Bioequivalence Study of TAK-536 Pediatric Formulation
Official Title  ICMJE A Randomized, Open-label, 2×2 Crossover, Phase I Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-536 Pediatric Formulations and TAK-536 Commercial Tablet in Healthy Adult Male Subjects
Brief Summary The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male participants.
Detailed Description This study was designed to evaluate the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation (dry syrup, granules) and a single oral dose of TAK-536 commercial tablet by using open-label, 2 × 2 crossover design.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Japanese Healthy Adult Males
Intervention  ICMJE
  • Drug: TAK-536 Tablet
    TAK-536 10 mg tablet
  • Drug: TAK-536 Dry Syrup Formulation
    TAK-536 dry syrup formulation
  • Drug: TAK-536 Ganule Formulation
    TAK-536 granule formulation
Study Arms  ICMJE
  • Experimental: Dry syrup formulation (Group a)
    One pack of the dry syrup formulation of TAK-536, containing 10 milligram (mg) of TAK-536, will be orally administered with water (200 milliliter [mL]) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.
    Interventions:
    • Drug: TAK-536 Tablet
    • Drug: TAK-536 Dry Syrup Formulation
  • Experimental: Dry syrup formulation (Group b)
    One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the dry syrup formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.
    Interventions:
    • Drug: TAK-536 Tablet
    • Drug: TAK-536 Dry Syrup Formulation
  • Experimental: Granule formulation (Group a)
    One pack of the granule formulation of TAK-536, containing 10 mg of TAK-536,will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.
    Interventions:
    • Drug: TAK-536 Tablet
    • Drug: TAK-536 Ganule Formulation
  • Experimental: Granule formulation (Group b)
    One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the granule formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2.
    Interventions:
    • Drug: TAK-536 Tablet
    • Drug: TAK-536 Ganule Formulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2015)
52
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
  3. The participant is a healthy Japanese adult male volunteer.
  4. The participant is between 20 and 35 years of age at the time of informed consent.
  5. The participant has a body weight of at least 50.0 kilogram (kg) and has a body mass index (BMI) between 18.5 and 25.0 kilogram per meter square (kg/m^2) at the time of screening.

Exclusion Criteria:

  1. The participant has shown symptoms of dizziness on standing up, facial pallor, cold sweat, etc, and suspected hypotension at medical examination/physical findings at screening and the day before administration of the study drug for Period 1, and before administration of the study drug for Period 1.
  2. The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study medication for Period 1
  3. The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
  4. The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
  5. The participant has a known hypersensitivity to TAK-536 or angiotensin II receptor blockers.
  6. The participant has positive results in the urine drug screening test at screening.
  7. The participant 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 or is unwilling to agree to abstain from alcohol and drugs throughout the study period.
  8. The participant has taken any excluded medication, supplements, or food products during the time periods.
  9. The participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention (ie, cholecystectomy).
  10. The participant has a history of cancer.
  11. The participant 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. The participant has poor peripheral venous access.
  13. The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study medication administration for Period 1.
  14. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study medication administration for Period 1.
  15. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration for Period 1.
  16. The participant has an abnormal (clinically significant) electro-cardiogram at screening or prior to the start of study medication for Period 1.
  17. The participant has abnormal laboratory values at screening or prior to the start of study medication for Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine transaminase (ALT) or aspartate transaminase (AST) greater than (>)1.5 times the upper limits of normal.
  18. The participant who, in the opinion of the investigator or the sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02401464
Other Study ID Numbers  ICMJE TAK-536/CPH-101
U1111-1168-3113 ( Registry Identifier: WHO )
JapicCTI-152853 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP