PMID- 28544344
OWN - NLM
STAT- MEDLINE
DCOM- 20190326
LR  - 20190326
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Linking)
VI  - 7
IP  - 2
DP  - 2018 Feb
TI  - Fed and Fasted Administration of a Novel Extended-Release Methylphenidate Orally 
      Disintegrating Tablet Formulation for the Treatment of ADHD.
PG  - 160-167
LID - 10.1002/cpdd.361 [doi]
AB  - Extended-release methylphenidate is a first-line treatment for 
      attention-deficit/hyperactivity disorder. A methylphenidate extended-release 
      orally disintegrating tablet (MPH XR-ODT) has recently been developed. Here we 
      report an open-label, randomized, 2-period, 2-treatment crossover study to 
      determine the effect of food on the bioavailability of a single 60-mg dose of MPH 
      XR-ODT in healthy adults. Blood samples were collected predose through 36 hours 
      postdose. Maximum plasma concentration (C(max) ), time to maximum plasma 
      concentration (T(max) ), terminal elimination half-life (T(1/2) ), overall 
      systemic exposure (AUC(last) and AUC(inf) ), and partial areas under the 
      concentration curve (AUC(0-3) , AUC(3-7) , and AUC(7-12) ) were calculated. In 
      total, 48 participants completed the study. For total methylphenidate from MPH 
      XR-ODT, the lower limit of the 90% confidence interval (CI) around the geometric 
      mean ratio (GMR, fed/fasted) for C(max) was below 80%, indicating a slightly 
      decreased rate of absorption with food, whereas the 90%CIs around the GMRs of 
      AUC(last) and AUC(inf) were within the 80%-125% limits, suggesting no food effect 
      on exposure. The most common adverse events (AEs) were palpitations and decreased 
      appetite. No serious, unusual, or unexpected AEs were reported. Thus, food had no 
      substantial effect on overall bioavailability of MPH XR-ODT, which may be an 
      important factor for some patients.
CI  - (c) 2017, The American College of Clinical Pharmacology.
FAU - Weisler, Richard H
AU  - Weisler RH
AD  - Duke University Medical Center, Durham, NC, USA.
AD  - University of North Carolina at Chapel Hill, Raleigh, NC, USA.
FAU - Stark, Jeffrey G
AU  - Stark JG
AD  - Worldwide Clinical Trials, Austin, TX, USA.
FAU - Sikes, Carolyn
AU  - Sikes C
AD  - Neos Therapeutics, Inc., Grand Prairie, TX, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170525
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dietary Fats)
RN  - 0 (Tablets)
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Area Under Curve
MH  - Attention Deficit Disorder with Hyperactivity/drug therapy
MH  - Biological Availability
MH  - Central Nervous System Stimulants/adverse effects/blood/*pharmacokinetics
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations/adverse effects/pharmacokinetics
MH  - Dietary Fats/*pharmacology
MH  - Fasting/*metabolism
MH  - Female
MH  - *Food-Drug Interactions
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Methylphenidate/adverse effects/blood/*pharmacokinetics
MH  - Tablets
MH  - Therapeutic Equivalency
MH  - Young Adult
OTO - NOTNLM
OT  - clinical research
OT  - clinical trials
OT  - drug delivery
OT  - methylphenidate
OT  - orally disintegrating tablet
OT  - pharmacokinetics and drug metabolism
OT  - psychiatry
EDAT- 2017/05/26 06:00
MHDA- 2019/03/27 06:00
CRDT- 2017/05/26 06:00
PHST- 2016/11/23 00:00 [received]
PHST- 2017/04/05 00:00 [accepted]
PHST- 2017/05/26 06:00 [pubmed]
PHST- 2019/03/27 06:00 [medline]
PHST- 2017/05/26 06:00 [entrez]
AID - 10.1002/cpdd.361 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2018 Feb;7(2):160-167. doi: 10.1002/cpdd.361. Epub 2017 
      May 25.