Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)

November 20, 2016 updated by: In-Jin Jang, MD, PhD, Seoul National University Hospital

A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011

This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients with chronic obstructive pulmonary disease (COPD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 8 A.M. in the morning of the drug administration day, followed by blood collection for evaluation of pharmacokinetics. The same schedule with increased dose will be proceeded after 14-day washout period.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 19 to 45, healthy male subjects (at screening)
  • Body weight between 55kg - 90kg, BMI (Body Mass Index) between 18.0 - 27.0
  • Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent

Exclusion Criteria:

  • Volunteer who has past or present history of any diseases such as liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder
  • Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
  • Subject who already participated in other trials in 3 months
  • Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhalation of HCP0910 and HGP1011

Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.

The periods were separated with a washout period of 14 days.
Drug: HCP0910 and HGP1011
Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))
Other Names:
  • Seretide 250 diskus and Spiriva capsule for inhalation
  • Fluticasone/Salmeterol and Tiotropium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration Versus Time Curve (AUClast)
Time Frame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration
Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Maximum Concentration (Tmax)
Time Frame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Time to maximum concentration of fluticasone
Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Maximum Observed Concentration (Cmax)
Time Frame: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Maximum observed concentration of fluticasone
Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: In-Jin Jang, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

November 20, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM_COPD_PILOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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