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Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block | Clinical Trials | Clareo Health

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Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block

A Single-Dose, Randomized, Open-Label, Crossover, Pivotal, Comparative Bioavailability Study of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in Healthy Volunteers Without Charcoal Block

NCT02466347•Intech Biopharm Ltd.

View on ClinicalTrials.gov

Summary

The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without charcoal block.

Detailed Description

A pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, crossover, comparative bioavailability study for test drug Synflutide HFA 250/25 Inhaler and reference drug SeretideTM 250 EvohalerTM in healthy volunteers without charcoal block. Fifty healthy, male and female volunteers, 20-65 years of age, with a body mass index (BMI) within 18.0-30.0 kg/m2, inclusive, will be enrolled. A single dose of 4 puffs (eq. to fluticasone propionate 1000μg+salmeterol 100μg from valve) in each study period. Plasma samples will be assayed for fluticasone propionate and salmeterol using a validated analytical method according to the principles of Good Laboratory Practice.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male and female volunteers, aged 20-65, inclusive.
•BMI that is within 18.0-30.0 kg/m², inclusive.
•Healthy or Non Clinical Significant, according to the medical history, ECG, Chest X-ray and physical examination as determined by the Principal Investigator/Sub-Investigator.
•Systolic blood pressure between 90-139 mmHg, inclusive, and diastolic blood pressure between 50-90 mmHg, inclusive, and pulse rate between 50-100 bpm, inclusive and temperature between 35.0-37.4℃.
•Clinical laboratory values within PPC's acceptable range according to PPC SOP VI-006.
•Ability to comprehend and be informed of the nature of the study, as assessed by PPC staff. Capable of giving written informed consent prior to receiving any study medication. Must be able to communicate effectively with clinic staff.
•Ability to fast for at least 14 hours and to consume standard meals.
•Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
•Agree not to have a tattoo or body piercing until the end of the study.
•Female subjects must fulfill at least one of the following:
+3 more criteria

Exclusion Criteria

•Known history or presence of any clinically significant hepatic (e.g. active liver disease, hepatic impairment), renal/genitourinary (e.g. renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine (e.g. hypothyroidism), immunological, musculoskeletal (e.g. myopathy, rhabdomyolysis), neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator.
•Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first drug administration, as determined by the Principal Investigator/Sub-Investigator.
•Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Principal Investigator/Sub-Investigator.
•Presence of any significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator.
•A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, tetrahydrocannabinol), breath alcohol test. Positive pregnancy test for female subjects.
•Known history or presence of:
•* Alcohol abuse or dependence within one year prior to first drug administration;
•* Drug abuse or dependence;
•* Hypersensitivity or idiosyncratic reaction to fluticasone propionate, salmeterol xinafoate, its excipients, and/or related substances;
•* Food allergies and/or presence of any dietary restrictions;
+17 more criteria

Locations (1)

Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch

New Taipei City, Taiwan

Key Dates

Start Date

June 1, 2014

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

July 26, 2016

Enrollment

ACTUAL participants

Conditions

AsthmaChronic Obstructive Pulmonary Disease (COPD)

Interventions

Fluticasone propionate

DRUG

Salmeterol (as xinafoate)

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma