CompletedPhase 1

Single Dose Pharmacokinetics of Egalet® Hydrocodone

Canada28 participantsStarted 2008-11

Plain-language summary

The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Non-smokers * ≥18 and ≤55 years of age * BMI ≥19 and ≤30.0 Exclusion Criteria: * Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment * History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening * Allergic to hydrocodone, hydromorphone, other opioids, or related drugs * Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration * Pregnant or breast-feeding

What they're measuring

To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24

Timeframe: Single-dose evaluation

Trial details

NCT IDNCT00802087

SponsorEgalet Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-12

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