Recruiting · registry statusComparing tablet and capsule forms of KDT3594
Researchers are comparing how the body absorbs two forms of this study medicine after a single dose.
Testing a treatment or activity · Study reference: JPRN-jRCT2031260257
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
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Looking for volunteers
- Start (reported date)
- 2026-06-25
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages >= 18age old to <= 45age old · Ask the team who can join
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: both
Inclusion criteria: 1)Participants who personally provide written informed consent to participate in the clinical trial
2)At the time of informed consent, participants aged >=18 and ==18.5 to =50 to =45 to <90 kg
Exclusion criteria: 1)Participants who have abnormal findings on medical examination, vital signs, or 12-lead ECG, which are considered clinically significant by the principal investigator or the subinvestigator
2)Male participants with a QTcF interval of >=450 msec or female participants with a QTcF interval of >=470 msec on a 12-lead ECG
3)Participants who have abnormal findings in the screening test or clinical laboratory tests on the day before KDT-3594 administration in Period I and are judged as clinically significant by the principal investigator or the subinvestigator
4)Participants who have experienced systolic blood pressure (standing) of =20 mmHg from the measurement in the supine position
5)Participants who tested positive for immunological tests (HBs antigen, HCV antibody, serologic test for syphilis, and HIV antigen/antibody) in the screening test
6)Participants who tested positive for the urine drug abuse test (phencyclidines, benzodiazepines, cocaine-based narcotics, stimulants, cannabis, morphine-based narcotics, barbiturates, and tricyclic antidepressants) in the screening test
7)Participants with a history of drug allergy
8)Participants with a history of repeated syncope or diagnosed cardiovascular or cerebrovascular abnormalities
9)Participants with a history or complication of orthostatic hypotension
10)Participants with a history of disease or surgery (e.g., gastrectomy and cholecystectomy) that may affect the absorption of the trial intervention
11)Regular drinkers consuming >40 g of pure alcohol per day on average
12)Participants who smoked cigarettes (including e-cigarettes) or consumed nicotine-containing products within 12 weeks before KDT-3594 administration in Period I
13)Participants who used other ethical drugs or OTC drugs (including vitamins or nutritional drinks) within 2 weeks before KDT-3594 administration in Period I (topical formulations not expecting systemic effects may be used)
14)Participants who took supplements known to affect pharmacokinetics (e.g., St. John's wort [Hypericum perforatum]) within 2 weeks before KDT-3594 administration in Period I
15)Participants who consumed grapefruit, orange, or food and drink containing grapefruit or orange within 1 week before KDT-3594 administration in Period I
16)Participants who have used a drug that alters the CYP3A or P-gp activity within 4 weeks (or >=5 times of the half-life, whichever is longer) before KDT-3594 administration in Period I
17)Participants who exercised excessively with fatigue or myalgia within 1 week before KDT-3594 administration in Period I
18)Participants who donated >400 mL of whole blood within 12 weeks, >200 mL of whole blood within 4 weeks, or any blood component within 2 weeks before KDT-3594 administration in Period I
19)Female participants who are pregnant, breastfeeding, planning to become pregnant during the study period, or who do not intend to use adequate contraception
20)Female participants with a positive pregnancy test at screening
21)Participants who received other trial interventions within 16 weeks before KDT-3594 administration in Period I (within 12 weeks for clinical trials of already approved drugs)
22)Participants previously treated with KDT-3594
23)Other participants judged as inappropriate for the trial by the principal investigator or subinvestigator
Full study name & original research details
Official study title
Bioequivalence study of KDT-3594 tablets and capsules
Short title used by the registry
Bioequivalence study of KDT-3594
Original description
Intervention:
A single oral dose of KDT-3594 tablets or KDT-3594 capsules will be administered on Day 1 of each of Period I and Period II.
Primary outcome:
Bioequivalence evaluation parameters of plasma KDT-3594 concentrations
Secondary outcome:
Incidence of adverse events and adverse drug reactions
Conditions reported: Parkinson disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- A single oral dose of KDT-3594 tablets or KDT-3594 capsules will be administered on Day 1 of each of Period I and Period II.
- Phases
- 1
- Sponsor
- Ikezaki Yumi
- Start date reported by registry
- 2026-06-25 (reported)
Registry updated: Not reported · Status last verified by the registry submitter: Not reported
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Yumi Ikezaki · +81-3-5684-3533 · rinsyousiken@pharm.kissei.co.jp
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
No locations reported. Ask the study team where participation is available.
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.