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Naloxone + hydromorphone is a fixed-dose combination oral tablet developed by Zenith Technology Corporation Limited for the management of moderate-to-severe pain. The product combines hydromorphone, a potent semi-synthetic opioid agonist that provides analgesia by acting primarily on mu-opioid receptors, with naloxone, an opioid receptor antagonist. Naloxone is included as an abuse-deterrent component; when taken orally, it undergoes extensive first-pass metabolism and has minimal systemic effect, but if the tablet is crushed and injected, naloxone blocks the effects of hydromorphone to prevent misuse. The formulation has been evaluated in Phase 1 randomized crossover bioequivalence studies to compare its pharmacokinetic profile against an innovator reference product.
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