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Dopamine Precursor

25 mg /150 mg treatment B group for Overactive Bladder

Phase 1
Waitlist Available
Led By Akash Patel, M.D.
Research Sponsored by Shanghai WD Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours-from morning of day 1 to morning of day 2
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed conditions. The primary objective of the study is to compare the pharmacokinetic profiles between WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects and to compare relative bioavailability between treatments.

Eligible Conditions
  • Overactive Bladder
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours-from morning of day 1 to morning of day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours-from morning of day 1 to morning of day 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Carbidopa
The duration (hours) for the levodopa concentrations ≥ 50% of Cmax between WD-1603 extended-release formulations and carbidopa and levodopa tablets following three times a day orally administration in healthy subjects.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: 25 mg /150 mg treatment D groupExperimental Treatment1 Intervention
Treatment D: carbidopa/levodopa (25 mg /150 mg)
Group II: 25 mg /150 mg treatment C groupExperimental Treatment1 Intervention
Treatment C: carbidopa/levodopa (25 mg /150 mg)
Group III: 25 mg /150 mg treatment B groupExperimental Treatment1 Intervention
Treatment B: carbidopa/levodopa (25 mg/150mg)
Group IV: 25 mg /100 mg treatment A groupExperimental Treatment1 Intervention
Treatment A: carbidopa/levodopa (25 mg /100 mg)
Group V: 25 mg /100 mg placebo groupPlacebo Group1 Intervention
Treatment E(Reference): Carbidopa and Levodopa tablets (a generic version of Sinemet® IR) 25 mg/100 mg

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Shanghai WD Pharmaceutical Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Akash Patel, M.D.Principal InvestigatorLambda Therapeutic Research Ltd.
~4 spots leftby Nov 2025