Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00398957
Eligibility Criteria:
Inclusion Criteria:
* Patients were non-smoking, healthy volunteers with body weight between 135 and 220 pounds and within +/- 10% of their recommended weight range for their height and body frame according to the Metropolitan Height and Weight Tables
* Patients had a negative baseline urine screen for drugs of abuse
* Patients did not have any clinically significant deviations from normal in any laboratory test value.
Exclusion Criteria:
* Patients intolerant of or hypersensitive to hydromorphone or naltrexone
* Patient with any gastrointestinal disorder that may affect the absorption of orally administered drugs
* Patients with depressed respiratory function
* Patient with impaired renal or hepatic function
* Patient with dependence to opiates
* pregnant or breast feeding
* Female patients of child bearing potential must have a negative pregnancy test each week prior to administration of study drug and required to be following a medically rhydromorphoneadministrationnaltrexone recognized contraceptive program prior to and during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT00398957
Study Brief:
Protocol Section:
NCT00398957