Novel method to assess gastric emptying in humans: the Pellet Gastric Emptying Test.
To further validate the Pellet Gastric Emptying Test (PGET) as a marker of gastric emptying, a randomized, four-way crossover study was conducted with 12 healthy subjects. The study consisted of oral co-administration of enteric coated caffeine (CAFF) and acetaminophen (APAP) pellets in four treatment phases: Same Size (100 kcal), Fasted, Small Liquid Meal (100 kcal), and Standard Meal (847 kcal). The time of first appearance of measurable drug marker in plasma, t(initial), was taken as the emptying time for the markers. Co-administration of same size enteric coated pellets of CAFF and APAP (0.7 mm in diameter) revealed no statistically significant differences in t(initial) values indicating that emptying was dependent only on size and not on chemical make-up of the pellets. Co-administration of different size pellets indicated that the smaller 0.7-mm diameter (CAFF) pellets were emptied and absorbed significantly earlier than the larger 3.6-mm diameter (APAP) pellets with both the Small Liquid Meal (by 35 min) and the Standard Meal (by 33 min) (P<0.05). The differences in emptying of the pellets were not significant in the Fasted Phase. The results suggest that the pellet gastric emptying test could prove useful in monitoring changes in transit times in the fasted and fed states and their impact on drug absorption.
Choe
S Y
SY
Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, NJ 08543-4000, USA.
Neudeck
B L
BL
Welage
L S
LS
Amidon
G E
GE
Barnett
J L
JL
Amidon
G L
GL
D000082:Acetaminophen / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D000704:Analysis of Variance; D019540:Area Under Curve; D002110:Caffeine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004343:Drug Implants / Q000008:administration & dosage / Q000493:pharmacokinetics; D005215:Fasting / Q000097:blood; D005260:Female; D018565:Food-Drug Interactions / Q000502:physiology; D005746:Gastric Emptying / Q000502:physiology*; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D013608:Tablets, Enteric-Coated / Q000008:administration & dosage / Q000493:pharmacokinetics*
D018712:Analgesics, Non-Narcotic; D000697:Central Nervous System Stimulants; D004343:Drug Implants; D013608:Tablets, Enteric-Coated; D000082:Acetaminophen; D002110:Caffeine