A Bioequivalence (BE) Study in Healthy Subjects
- Registration Number
- NCT01177943
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4 milligrams per milliliter \[mg/mL\]) compared with 2 capsules of atomoxetine (25 mg per capsule) in healthy adult male Japanese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Atomoxetine Oral Solution Atomoxetine - Atomoxetine Capsule Formulation Atomoxetine -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇯🇵Fukuoka, Japan