Trial record 71 of 1121 for:
tablet | Japan
A Bioequivalence Study of TAK-536 Pediatric Formulation
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ClinicalTrials.gov Identifier: NCT02401464 |
Recruitment Status :
Completed
First Posted : March 27, 2015
Results First Posted : July 6, 2016
Last Update Posted : July 6, 2016
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Japanese Healthy Adult Males |
Interventions |
Drug: TAK-536 Tablet Drug: TAK-536 Dry Syrup Formulation Drug: TAK-536 Ganule Formulation |
Enrollment | 52 |
Participant Flow
Recruitment Details | Participants took part in the study at 1 investigative site in Japan from 25 March 2015 to 26 May 2015. |
Pre-assignment Details | Healthy participants were enrolled in 1 of 2 treatment sequences: Sequence a (dry syrup): TAK-536 dry syrup followed by TAK-536 tablet; Sequence b (dry syrup): TAK-536 tablet followed by TAK-536 dry syrup; Sequence a (granules): TAK-536 granules followed by TAK-536 tablet; Sequence b (granules): TAK-536 tablet followed by TAK-536 granules. |
Arm/Group Title | Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet | Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup | Granule Cohort: TAK-536 Granules + TAK-536 Tablet | Granule Cohort: TAK-536 Tablet + TAK-536 Granules |
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Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). | Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days). | Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). | Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days). |
Period Title: Intervention Period 1 (6 Days) | ||||
Started | 13 | 13 | 13 | 13 |
Completed | 13 | 13 | 13 | 13 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Washout Period (At Least 6 Days) | ||||
Started | 13 | 13 | 13 | 13 |
Completed | 13 | 13 | 13 | 13 |
Not Completed | 0 | 0 | 0 | 0 |
Period Title: Intervention Period 2 (6 Days) | ||||
Started | 13 | 13 | 13 | 13 |
Completed | 13 | 13 | 13 | 13 |
Not Completed | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet | Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup | Granule Cohort: TAK-536 Granules + TAK-536 Tablet | Granule Cohort: TAK-536 Tablet + TAK-536 Granules | Total | |
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Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). | Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days). | Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). | Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days). | Total of all reporting groups | |
Overall Number of Baseline Participants | 13 | 13 | 13 | 13 | 52 | |
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The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 13 participants | 13 participants | 13 participants | 13 participants | 52 participants | |
25.3 (2.21) | 25.9 (4.11) | 26.6 (4.07) | 27.4 (5.71) | 26.308 (4.16) | ||
Sex/Gender, Customized
Measure Type: Number Unit of measure: Participants |
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Male | Number Analyzed | 13 participants | 13 participants | 13 participants | 13 participants | 52 participants |
13 | 13 | 13 | 13 | 52 | ||
Smoking classification
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 13 participants | 13 participants | 52 participants |
Never smoked | 7 | 9 | 7 | 8 | 31 | |
Current smoker | 0 | 0 | 1 | 1 | 2 | |
Ex-smoker | 6 | 4 | 5 | 4 | 19 | |
Alcohol classification
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 13 participants | 13 participants | 52 participants |
Drank a few days per week | 1 | 2 | 2 | 0 | 5 | |
Drank a few days per month | 1 | 3 | 3 | 3 | 10 | |
Never drank | 11 | 8 | 8 | 10 | 37 | |
Caffeine Classification
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 13 participants | 13 participants | 52 participants |
Had caffeine consumption | 2 | 3 | 6 | 5 | 16 | |
Had no caffeine consumption | 11 | 10 | 7 | 8 | 36 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: | Medical Director |
Organization: | Takeda |
Phone: | +1-877-825-3327 |
EMail: | trialdisclosures@takeda.com |
Responsible Party: | Takeda |
ClinicalTrials.gov Identifier: | NCT02401464 |
Other Study ID Numbers: |
TAK-536/CPH-101 U1111-1168-3113 ( Registry Identifier: WHO ) JapicCTI-152853 ( Registry Identifier: JapicCTI ) |
First Submitted: | March 24, 2015 |
First Posted: | March 27, 2015 |
Results First Submitted: | May 25, 2016 |
Results First Posted: | July 6, 2016 |
Last Update Posted: | July 6, 2016 |