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A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers

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Trial Profile

A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Sep 2026

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At a glance

  • Drugs Raltegravir (Primary) ; Aluminium hydroxide/magnesium hydroxide; Aluminium hydroxide/magnesium hydroxide/simethicone; Citric acid/potassium bicarbonate/sodium bicarbonate; Multivitamin; Sodium bicarbonate
  • Indications Dyspepsia; Gastro-oesophageal reflux; Gastrointestinal ulcer; HIV-1 infections
  • Focus Pharmacokinetics
  • Acronyms RalpH

Most Recent Events

  • 17 Aug 2026 Study design changed from parallel to crossover. The primary endpoint was clarified by adding the specific PK sampling time points (pre-dose through 12 hours post-dose) on Days 1, 6, 11, 16, and 21. The time frame was also clarified to specify the 0-12-hour dosing period.
  • 24 Feb 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
  • 08 Jan 2016 Planned End Date changed from 1 Dec 2015 to 1 Mar 2016 as reported by ClinicalTrials.gov.

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