NCT01487512

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

December 5, 2011

Last Update Submit

November 15, 2012

Conditions

Healthy Volunteers

Keywords

Healthy VolunteersDose ProportionalityPharmacokineticsOROS HydromorphoneHydromorphoneTaiwan

Outcome Measures

Primary Outcomes (1)

  • Plasma hydromorphone concentrations

    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.

    20 time points up to 72 hours post-dose

Secondary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    Approximately 12 weeks

Study Arms (4)

Sequence 1: Treatment A-D-B-C

EXPERIMENTAL

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.

Drug: Treatment A: Hydromorphone 8 mgDrug: Treatment B: Hydromorphone 16 mgDrug: Treatment C: Hydromorphone 32 mgDrug: Treatment D: Hydromorphone 64 mg

Sequence 2: Treatment B-A-C-D

EXPERIMENTAL

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.

Drug: Treatment A: Hydromorphone 8 mgDrug: Treatment B: Hydromorphone 16 mgDrug: Treatment C: Hydromorphone 32 mgDrug: Treatment D: Hydromorphone 64 mg

Sequence 3: Treatment C-B-D-A

EXPERIMENTAL

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.

Drug: Treatment A: Hydromorphone 8 mgDrug: Treatment B: Hydromorphone 16 mgDrug: Treatment C: Hydromorphone 32 mgDrug: Treatment D: Hydromorphone 64 mg

Sequence 4: Treatment D-C-A-B

EXPERIMENTAL

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.

Drug: Treatment A: Hydromorphone 8 mgDrug: Treatment B: Hydromorphone 16 mgDrug: Treatment C: Hydromorphone 32 mgDrug: Treatment D: Hydromorphone 64 mg

Interventions

Treatment A: Hydromorphone 8 mgDRUG

type= exact number, unit= mg, number= 8, form= tablet, route= oral use. One tablet of Hydromorphone 8 mg in each of 4 treatment sequences.

Sequence 1: Treatment A-D-B-CSequence 2: Treatment B-A-C-DSequence 3: Treatment C-B-D-ASequence 4: Treatment D-C-A-B
Treatment B: Hydromorphone 16 mgDRUG

type= exact number, unit= mg, number= 16, form= tablet, route= oral use. One tablet of Hydromorphone 16 mg in each of 4 treatment sequences.

Sequence 1: Treatment A-D-B-CSequence 2: Treatment B-A-C-DSequence 3: Treatment C-B-D-ASequence 4: Treatment D-C-A-B
Treatment C: Hydromorphone 32 mgDRUG

type= exact number, unit= mg, number= 32, form= tablet, route= oral use. One tablet of Hydromorphone 32 mg in each of 4 treatment sequences.

Sequence 1: Treatment A-D-B-CSequence 2: Treatment B-A-C-DSequence 3: Treatment C-B-D-ASequence 4: Treatment D-C-A-B
Treatment D: Hydromorphone 64 mgDRUG

type= exact number, unit= mg, number= 64, form= tablet, route= oral use. One tablet of Hydromorphone 64 mg in each of 4 treatment sequences.

Sequence 1: Treatment A-D-B-CSequence 2: Treatment B-A-C-DSequence 3: Treatment C-B-D-ASequence 4: Treatment D-C-A-B

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Taipei, Taiwan

Location

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

TW(1)