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

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: HCP0910 and HGP1011

• Registration Number: NCT02441114
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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).

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 Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2015-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-04-24
• Results First Submitted QC: 2016-06-01
• Results First Posted: 2016-07-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inhalation of HCP0910 and HGP1011	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve (AUClast)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of