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Woodland International Research Group
Schizophrenia Bipolar Phase 1 Case Study
An Open-Label, Randomized, Two Treatment, Multi-Site, Multiple Dose, Steady State, Three-Way, Reference-Replicated Crossover, Pharmacokinetic Study To Determine The In-Vivo Bioequivalence Between XXXXX XXmg Sublingual Tablet And XXXX XXmg Sublingual Tablet
Key Elements
- Rescue Study
- Ultra Rapid Startwith high retention
~91%
Completion Rate, compared to a study average of 75%
~26%
of study enrollment out of 8 total sites completed by Woodland
9
PK lab draws per subject
Phase: 1
Indication: Schizophrenia (Stable) or Bipolar (stable) subjects
Rapid Study Start-up: Contracting, regulatory, and site initiation completed within 48 hours
# of Subjects: 11 (study average was 5-6 completed subjects per site)
In-patient Period: 6 full bed days with an additional 11.5 days of non-treatment, confinement days per subject
Completion Rate: ~91% compared to a study average of 75%
Other Study Information: Woodland completed ~26% of study enrollment out of 8 total sites
Objectives
Primary
Establish the pharmacokinetic bioequivalence between XXXXX sublingual tablets and XXXXX sublingual tablets.ECGs—5 per subject
Secondary
Compare the safety profiles of the test and referenceproducts by examining the adverse events profiles of thetwo products.
PK Lab Draws—9 per subject
Day 5, Day 6, Day 12, Day 13, Day 19 and Day 20. PK drawsperformed on days 7, 14 and 21 at hour 0 (pre-dose),0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0.All pre-dose draws were performed within 5 minutesprior to dosing.
Vitals—14 per subject
Daily
- Assessed within 15 minutes before and within 30minutes after the morning dose
ECGs—5 per subject
Day -7
Day 1
Day 8
Day 15
Day 24
Standard 12-lead ECGsHematology / Chemistry—6 per subject
Day -7
Day 1
Day 7
Day14
Day 21
Day 24
