OP-2024-006 Study

Not yet recruiting

• Conditions: Parkinson's disease

• Registration Number: jRCT2031250157
• Lead Sponsor: OHARA Pharmaceuitical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-11
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Healthy Japanese male.
2. BMI at time of screening is >= 18.5 to < 25.0.
3. Written informed consent to participate in this trial can be obtained.

Exclusion Criteria

1. History of allergies to any component of the investigational product, drug, or food.
2. Subjects with or at risk for angle-closure glaucoma.
3. Subjects with pheochromocytoma or paraganglioma, or other catecholamine-secreting tumors.
4. History of neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
5. History of diseases affecting the gastrointestinal tract, liver, kidneys, or heart that may influence the absorption, distribution, metabolism, or excretion of drugs.
6. History of major surgery involving the gastrointestinal tract, including gastrectomy, gastrostomy, or bowel resection (excluding appendectomy).

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Pharmacokinetics