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Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01487512
First received: December 5, 2011
Last updated: November 15, 2012
Last verified: November 2012
History of Changes

December 5, 2011
November 15, 2012
March 2011
July 2011   (final data collection date for primary outcome measure)
Plasma hydromorphone concentrations [ Time Frame: 20 time points up to 72 hours post-dose ] [ Designated as safety issue: No ]
Sequential blood samples are collected over 72 hours during each treatment period. The study has a total of four 5-day treatment periods. The treatment periods are separated by a 7- to 14-day washout period.
Plasma hydromorphone concentrations [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Sequential blood samples are collected over 72 hours during each treatment period. The study has a total of four 5-day treatment periods. The treatment periods are separated by a 7- to 14-day washout period.
Complete list of historical versions of study NCT01487512 on ClinicalTrials.gov Archive Site
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants
A Single-Dose, Open-Label, Randomized, Crossover Dose Proportionality Study to Evaluate the Effect of Dose on the Pharmacokinetics of 8, 16, 32 and 64 mg OROS Hydromorphone Under Fasted Conditions in Healthy Adult Taiwanese Subjects

The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in healthy adult Taiwanese participants after oral administration of 4 different dose strengths of 8, 16, 32 and 64 mg under fasted conditions.

This is a single-center, randomized (study drug assigned by chance like flipping a coin), open-label (all people involved know the identity of the intervention), 4-way crossover (participants receive different interventions sequentially during the trial) study in healthy adult Taiwanese participants. All participants will be randomly assigned to 1 of the 4 different possible treatment sequences and will receive all treatments in the order specified by the randomization schedule. The study consists of a screening phase, an open-label treatment phase consisting of 4 single-dose treatment periods, and end-of-study or withdrawal assessments. During the open-label treatment periods, the participants will stay in the center until completion of the 72-hour pharmacokinetics [PK] (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) blood sample on Day 4. A 7- to 14-day washout period (period when receiving no treatment) will separate the open-label treatment periods. The safety and tolerability will be evaluated over the investigated dose range. The duration of participation in the study for an individual participant will be approximately 12 weeks.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Treatment A: Hydromorphone 8 mg
    type= exact number, unit= mg, number= 8, form= tablet, route= oral use. One tablet of Hydromorphone 8 mg in each of 4 treatment sequences.
  • Drug: Treatment B: Hydromorphone 16 mg
    type= exact number, unit= mg, number= 16, form= tablet, route= oral use. One tablet of Hydromorphone 16 mg in each of 4 treatment sequences.
  • Drug: Treatment C: Hydromorphone 32 mg
    type= exact number, unit= mg, number= 32, form= tablet, route= oral use. One tablet of Hydromorphone 32 mg in each of 4 treatment sequences.
  • Drug: Treatment D: Hydromorphone 64 mg
    type= exact number, unit= mg, number= 64, form= tablet, route= oral use. One tablet of Hydromorphone 64 mg in each of 4 treatment sequences.
  • Experimental: Sequence 1: Treatment A-D-B-C
    The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days.
    Interventions:
    • Drug: Treatment A: Hydromorphone 8 mg
    • Drug: Treatment B: Hydromorphone 16 mg
    • Drug: Treatment C: Hydromorphone 32 mg
    • Drug: Treatment D: Hydromorphone 64 mg
  • Experimental: Sequence 2: Treatment B-A-C-D
    The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days.
    Interventions:
    • Drug: Treatment A: Hydromorphone 8 mg
    • Drug: Treatment B: Hydromorphone 16 mg
    • Drug: Treatment C: Hydromorphone 32 mg
    • Drug: Treatment D: Hydromorphone 64 mg
  • Experimental: Sequence 3: Treatment C-B-D-A
    The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days.
    Interventions:
    • Drug: Treatment A: Hydromorphone 8 mg
    • Drug: Treatment B: Hydromorphone 16 mg
    • Drug: Treatment C: Hydromorphone 32 mg
    • Drug: Treatment D: Hydromorphone 64 mg
  • Experimental: Sequence 4: Treatment D-C-A-B
    The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days.
    Interventions:
    • Drug: Treatment A: Hydromorphone 8 mg
    • Drug: Treatment B: Hydromorphone 16 mg
    • Drug: Treatment C: Hydromorphone 32 mg
    • Drug: Treatment D: Hydromorphone 64 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria: - Body mass index (BMI) between 18 and 25 kg/m², inclusive and a body weight of not less than 50 kg - Participants must utilize a medically acceptable method of contraception throughout the entire study period and for 1 month after the study is completed - Each participant will receive a naloxone challenge test for opioid dependency at screening. Only those participants who pass this challenge test will be allowed to continue in the study Exclusion Criteria: - History of or current clinically medical illness or any other condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results - Clinically significant abnormal values for hematology, clinical chemistry or urinalysis - Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) - Use of certain prescription or nonprescription medication, and consumption of products that may interfere with the study
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01487512
CR017692, 42801PAI1010
No
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP