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Greater Immediate Gastric Acid Suppression with Lansoprazole 30 mg Administered as a 2‐Minute Intravenous Bolus Injection versus a 30‐Minute Infusion
Author(s) -
Metz David C.,
Devlin John W.,
Vakily Majid,
Atkinson Stuart,
Lloyd Eric
Publication year - 2008
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.28.3.301
Subject(s) - lansoprazole , saline , pharmacokinetics , bolus (digestion) , medicine , crossover study , placebo , volunteer , bioequivalence , anesthesia , pharmacodynamics , regimen , omeprazole , pharmacology , surgery , alternative medicine , pathology , agronomy , biology
Study Objective. To compare the pharmacokinetics, pharmacodynamics, and safety of lansoprazole administered as a 2‐minute intravenous bolus injection versus a 30‐minute continuous infusion. Design. Phase I, open‐label, randomized, crossover, single‐center trial. Setting. Clinical research facility. Subjects. Thirty‐eight healthy volunteers aged 18–55 years. Intervention. Each subject received one of three regimens. Each regimen contained the same three treatments but in a different sequence: an intravenous injection of lansoprazole 30 mg/10 ml of normal saline over 2 minutes, an infusion of lansoprazole 30 mg/60 ml of normal saline over 30 minutes, and an intravenous injection of 10 ml of normal saline (placebo) over 2 minutes. Each treatment was administered once/day for 7 days, with a washout period of at least 5 days separating each one. Measurements and Main Results. Blood samples were assayed for lansoprazole concentrations by using liquid chromatography with tandem mass spectrometry. After the 2‐minute administration, mean peak lansoprazole concentrations were about 2‐fold higher than those after the 30‐minute administration on days 1 and 7. Lansoprazole area under the concentration versus time curve met criteria for bioequivalence on both days. Two‐minute administration resulted in a greater percentage of time that the 24‐hour pH was above 4 compared with the 30‐minute administration (53% vs 47%, p=0.045), with comparable 24‐hour integrated gastric acidity (114.4 vs 91.6 mmol • hr/L for 2‐min vs 30‐min, p=0.335). Significantly greater acid suppression occurred during the first hour after the 2‐minute administration compared with that after the 30‐minute administration (p≥0.001). Safety profiles were similar among the regimens. Conclusion. Greater immediate gastric acid suppression occurred after administration of lansoprazole 30 mg over 2 minutes than over 30 minutes, with other pharmacokinetic, pharmacodynamic, and safety profiles being similar.