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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: HCP0910 and HGP1011

Study type: Interventional

Funder types: Other

Identifiers

NCT02441114

HM_COPD_PILOT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Inhalation of HCP0910 and HGP1011

Experimental group

Description:

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.

Treatment:

Drug: HCP0910 and HGP1011