Clinical trials: Clinical Pharmacology
- Condition Clinical Pharmacology
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Asthma
Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult Patients
This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber…
- Trial name
- ADO pMDI (NCT01803087)
- Testing
- Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1, CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2)., BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF)
- Where
- Poland
- Volunteers
- 60 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old
The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate…
- Trial name
- NCT02787967
- Testing
- CHF 1535 35/4µg NEXThaler®, free comb. beclomethasone DPI and formoterol DPI
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11…
- Trial name
- PAED1 (NCT01848769)
- Testing
- CHF1535 pMDI + AC Plus, BDP + AC Plus, Formoterol + AC Plus
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.
- Trial name
- NCT06900816
- Testing
- CHF 6001
- Where
- Bulgaria
- Volunteers
- 50 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.
The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater…
- Trial name
- ADONE (NCT01191424)
- Testing
- CHF1535 NEXT DPI, BDP DPI and formoterol DPI
- Where
- 2 sites in Denmark, United Kingdom
- Volunteers
- 57 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital
Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.
- Trial name
- NCT02094430
- Testing
- biological: human fibrinogen concentrate
- Where
- 4 sites in France, Lebanon and 2 more
- Volunteers
- 16 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Duchenne Muscular Dystrophy
A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)
This study is designed to evaluate the ability of ataluren to increase dystrophin protein levels in muscle cells of participants with nmDMD.
- Trial name
- NCT03648827
- Testing
- Ataluren
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- PTC Therapeutics
Cerebral Infarction
Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study
Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.
- Trial name
- NCT00147303
- Testing
- MCI-9042
- Volunteers
- 46 people
- Sponsor
- Tanabe Pharma Corporation
Asthma in Children
Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old
This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
- Trial name
- PAED4 (NCT01468272)
- Testing
- free comb. beclomethasone DPI and formoterol DPI, CHF 1535 50/6 NEXT DPI
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hyperbilirubinemia
Safety and Pharmacology of Stanate
The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.
- Trial name
- NCT00115544
- Testing
- Stanate
- Where
- Vietnam
- Volunteers
- 55 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company