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Study on the absorption of indicator components after ingestion of a new sustained-release formulation

Study on the absorption of indicator components after ingestion of a new sustained-release formulation -A randomized, single blind, 2-way, 2-period, cross-over study- - Study on the absorption of indicator components after ingestion of a new sustained-release formulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050522
Enrollment
10
Registered
2023-03-08
Start date
2023-03-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult men

Interventions

Intake of control - washout period - intake of test food (single ingestion). Intake of test food - washout period - intake of control (single ingestion).

Sponsors

FANCL Corporation
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Males 20 to 49 years of age. 2) Subjects whose BMI are more than 18.5 kg/m2 less than 25.0 kg/m2.

Exclusion criteria

Exclusion criteria: 1) Subjects with a serious medical history or gastrointestinal surgery. 2) Subjects with diseases affecting gastric excretion and digestion/absorption, or with daily symptoms of indigestion, constipation, diarrhea, etc. 3) Subjects have abnormal renal, hepatic, glucose and lipid metabolic functions. 4) Subjects are taking indicator components-rich drugs or supplements. 5) Subjects are heavy alcohol drinkers or excessive smokers. 6) Subjects who are judged to be unsuitable as subjects by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Total urinary excretion of indicator components per 24 hours after ingestion

Secondary

MeasureTime frame
Urinary indicator components excretion at each time point after ingestion. Tmax of urinary indicator components, Cmax of urinary indicator components.

Countries

Japan

Contacts

Public ContactChie Tarumizu

FANCL Corporation Research Institute

chie_0904@fancl.co.jp045-820-3443

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026