Trial Outcomes & Findings for Determination of Absorption and Elimination of Lamotrigine-XR (NCT NCT00789113)

Results Overview

To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

1 week

Results posted on

2016-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Extended Release Lamotrigine Extended Release Lamotrigine Extended Release Lamotrigine
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determination of Absorption and Elimination of Lamotrigine-XR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Release Lamotrigine n=12 Participants Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
Age, Customized Age 65 and older	12 participants n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	12 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 week

To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.

Outcome measures

Outcome measures
Measure	Immediate Release (IR) Lamotrigine n=12 Participants Study population was on chronic IR lamotrigine therapy and first period of the study was a continuation of standard treatment with IR lamotrigine.	Extended Release Lamotrigine n=12 Participants Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG	142.8 µg*h/mL Interval 92.4 to 220.7	132.3 µg*h/mL Interval 88.1 to 198.8

Adverse Events

Extended Release Lamotrigine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rory P. Remmel

University of Minnesota College of Pharmacy

Phone: 6126240472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place