Trial Outcomes & Findings for A Bioequivalence (BE) Study in Healthy Subjects (NCT NCT01177943)

NCT ID: NCT01177943

Last Updated: 2011-10-27

Results Overview

The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 42 participants
• Primary outcome timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose
• Results posted on: 2011-10-27

Participant Flow

Participant milestones

Measure	Atomoxetine Oral Solution First, Then Capsule Formulation Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters \[mL\] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.	Atomoxetine Capsule Formulation First, Then Oral Solution Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
First Intervention STARTED	21	21
First Intervention COMPLETED	19	21
First Intervention NOT COMPLETED	2	0
Second Intervention STARTED	19	21
Second Intervention COMPLETED	19	21
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Atomoxetine Oral Solution First, Then Capsule Formulation Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters \[mL\] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.	Atomoxetine Capsule Formulation First, Then Oral Solution Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
First Intervention Withdrawal by Subject	2	0

Baseline Characteristics

A Bioequivalence (BE) Study in Healthy Subjects

Baseline characteristics by cohort

Measure	Atomoxetine Oral Solution First, Then Capsule Formulation n=21 Participants Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.	Atomoxetine Capsule Followed by Oral Solution n=21 Participants Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).	Total n=42 Participants Total of all reporting groups
Age Continuous	23.0 years STANDARD_DEVIATION 4.4 • n=5 Participants	23.4 years STANDARD_DEVIATION 2.9 • n=7 Participants	23.2 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Japan	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants
weight (kg)	62.29 kilograms (kg) STANDARD_DEVIATION 7.29 • n=5 Participants	61.28 kilograms (kg) STANDARD_DEVIATION 5.90 • n=7 Participants	61.79 kilograms (kg) STANDARD_DEVIATION 6.57 • n=5 Participants

PRIMARY outcome

Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose

Population: All participants who had a Cmax value were included in the Cmax analysis.

The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.

Outcome measures

Measure	Atomoxetine Oral Solution n=42 Participants Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).	Atomoxetine Capsule Formulation n=40 Participants Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
Maximum Observed Plasma Concentration (Cmax)	456 nanogram per millileter (ng/mL) Interval 420.0 to 496.0	483 nanogram per millileter (ng/mL) Interval 443.0 to 526.0

PRIMARY outcome

Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose

Population: All participants who had an AUC value were included in the AUC analysis.

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.

Outcome measures

Measure	Atomoxetine Oral Solution n=42 Participants Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).	Atomoxetine Capsule Formulation n=40 Participants Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]	2220 nanogram hour per milliliter (ng*h/mL) Interval 1950.0 to 2540.0	2150 nanogram hour per milliliter (ng*h/mL) Interval 1880.0 to 2450.0

Adverse Events

Atomoxetine Oral Solution

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Atomoxetine Capsule Formulation

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Atomoxetine Oral Solution n=42 participants at risk Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).	Atomoxetine Capsule Formulation n=40 participants at risk Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
Gastrointestinal disorders Nausea	14.3% 6/42 • Number of events 6	12.5% 5/40 • Number of events 5
Investigations Blood pressure increased	7.1% 3/42 • Number of events 3	5.0% 2/40 • Number of events 2

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 1-800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60