Phase 1
Completed N=10
Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02441114 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Area Under the Concentration Versus Time Curve (AUClast) — 686.98; 1247.63; 1769.58 h*pg/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration Versus Time Curve (AUClast) |
686.98; 1247.63; 1769.58 | — |
| SECONDARY Time to Maximum Concentration (Tmax) |
0.76; 0.50; 0.88 | — |
| SECONDARY Maximum Observed Concentration (Cmax) |
95.70; 173.56; 246.77 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02441114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.