Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole
Background: The pharmacokinetics and pharmacodynamics of a novel orally disintegrating tablet (ODT) formulation of delayed-release dexlansoprazole 30 mg was evaluated versus the dexlansoprazole 30 mg capsule in this phase I, open-label, multiple-dose, randomized, two-period crossover study. Methods:...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2016-11-01
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| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/1756283X16670073 |
| _version_ | 1818306923672371200 |
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| author | Michael Kukulka Sai Nudurupati Maria Claudia Perez |
| author_facet | Michael Kukulka Sai Nudurupati Maria Claudia Perez |
| author_sort | Michael Kukulka |
| collection | DOAJ |
| description | Background: The pharmacokinetics and pharmacodynamics of a novel orally disintegrating tablet (ODT) formulation of delayed-release dexlansoprazole 30 mg was evaluated versus the dexlansoprazole 30 mg capsule in this phase I, open-label, multiple-dose, randomized, two-period crossover study. Methods: Healthy adults received daily doses of 30 mg dexlansoprazole ODT or 30 mg dexlansoprazole delayed-release capsule for 5 days during two treatment periods, separated by a 7-day washout interval. Blood samples for dexlansoprazole plasma concentrations and intragastric pH measurements were collected through 24 hours postdose on days 1 and 5 of each period. Results: Bioequivalence between the 30 mg ODT and 30 mg capsule dosage forms was demonstrated by the primary endpoints of dexlansoprazole peak concentration ( C max ) and systemic exposure (AUC) values contained within the prespecified 90% confidence interval (CI) range of 0.80–1.25. Additional primary endpoints of intragastric mean pH values and percentage of time with pH > 4 over the 24-hour postdose interval were equivalent for dexlansoprazole ODT and dexlansoprazole capsule. Treatment-emergent adverse events were reported in 23% and 28% of participants receiving the ODT and capsule formulations, respectively. Headache was the most common adverse event in both treatment regimens (5.8% with ODT and 6.0% with capsule). Conclusions: Administration of dexlansoprazole 30 mg ODT or 30 mg capsule provided equivalent plasma exposure when either was administered as a single dose or as once daily doses for 5 days. Pharmacodynamic equivalence between the two formulations was demonstrated by similar intragastric pH parameters on both day 1 and day 5. No effect of day on dexlansoprazole pharmacokinetics was observed. Dexlansoprazole ODT and dexlansoprazole capsule were both well tolerated. |
| first_indexed | 2024-12-13T06:50:12Z |
| format | Article |
| id | doaj.art-95df0d4dc18f4219a3f90b59664a8f6c |
| institution | Directory Open Access Journal |
| issn | 1756-283X 1756-2848 |
| language | English |
| last_indexed | 2024-12-13T06:50:12Z |
| publishDate | 2016-11-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj.art-95df0d4dc18f4219a3f90b59664a8f6c2022-12-21T23:56:10ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-283X1756-28482016-11-01910.1177/1756283X16670073Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazoleMichael KukulkaSai NudurupatiMaria Claudia PerezBackground: The pharmacokinetics and pharmacodynamics of a novel orally disintegrating tablet (ODT) formulation of delayed-release dexlansoprazole 30 mg was evaluated versus the dexlansoprazole 30 mg capsule in this phase I, open-label, multiple-dose, randomized, two-period crossover study. Methods: Healthy adults received daily doses of 30 mg dexlansoprazole ODT or 30 mg dexlansoprazole delayed-release capsule for 5 days during two treatment periods, separated by a 7-day washout interval. Blood samples for dexlansoprazole plasma concentrations and intragastric pH measurements were collected through 24 hours postdose on days 1 and 5 of each period. Results: Bioequivalence between the 30 mg ODT and 30 mg capsule dosage forms was demonstrated by the primary endpoints of dexlansoprazole peak concentration ( C max ) and systemic exposure (AUC) values contained within the prespecified 90% confidence interval (CI) range of 0.80–1.25. Additional primary endpoints of intragastric mean pH values and percentage of time with pH > 4 over the 24-hour postdose interval were equivalent for dexlansoprazole ODT and dexlansoprazole capsule. Treatment-emergent adverse events were reported in 23% and 28% of participants receiving the ODT and capsule formulations, respectively. Headache was the most common adverse event in both treatment regimens (5.8% with ODT and 6.0% with capsule). Conclusions: Administration of dexlansoprazole 30 mg ODT or 30 mg capsule provided equivalent plasma exposure when either was administered as a single dose or as once daily doses for 5 days. Pharmacodynamic equivalence between the two formulations was demonstrated by similar intragastric pH parameters on both day 1 and day 5. No effect of day on dexlansoprazole pharmacokinetics was observed. Dexlansoprazole ODT and dexlansoprazole capsule were both well tolerated.https://doi.org/10.1177/1756283X16670073 |
| spellingShingle | Michael Kukulka Sai Nudurupati Maria Claudia Perez Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole Therapeutic Advances in Gastroenterology |
| title | Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole |
| title_full | Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole |
| title_fullStr | Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole |
| title_full_unstemmed | Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole |
| title_short | Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole |
| title_sort | pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole |
| url | https://doi.org/10.1177/1756283X16670073 |
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