10 completed, 1 recruiting. 6 Phase 1, 3 Not applicable, 1 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 6 |
| Not applicable | 3 | Completed 2, Recruiting 1 |
| Phase 2 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma Albuterol Sulfate inhalation aerosol 108 mcg per actuation, Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation, Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo - Mild Asthma | Not applicable | Recruiting | Intech Biopharm Ltd. | 148 | 2022-08-15 | 2025-02-17 |
| Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions Albuterol Sulfate Inhalation Aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation - Healthy | Not applicable | Completed | Intech Biopharm Ltd. | 60 | 2022-02-24 | 2024-03-18 |
| Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions Albuterol Sulfate inhalation aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation - Healthy | Not applicable | Completed | Intech Biopharm Ltd. | 60 | 2021-03-19 | 2024-03-18 |
| Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients Budesonide 200 microgram/Puff, HFA MDI, Budesonide 100 microgram/Actuation Powder for Inhalation - Asthma | Phase 4 | Completed | Intech Biopharm Ltd. | 270 | 2019-04-22 | 2021-12-09 |
| A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block Budesonide, Formoterol - Asthma, COPD | Phase 1 | Completed | Intech Biopharm Ltd. | 99 | 2017-06-19 | 2020-07-31 |
| A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block Budesonide, Formoterol - Asthma, Chronic Obstructive Pulmonary Disease (COPD) | Phase 1 | Completed | Intech Biopharm Ltd. | 99 | 2016-03-01 | 2016-08-01 |
| Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block Fluticasone propionate, Salmeterol (as xinafoate) - Asthma, Chronic Obstructive Pulmonary Disease (COPD) | Phase 1 | Completed | Intech Biopharm Ltd. | 45 | 2014-08-01 | 2015-06-09 |
| Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block Fluticasone propionate, Salmeterol (as xinafoate) - Asthma, Chronic Obstructive Pulmonary Disease (COPD) | Phase 1 | Completed | Intech Biopharm Ltd. | 45 | 2014-06-01 | 2016-07-26 |
| Efficacy Study of SYN006 HFA MDI in Asthma Patients Budesonide/Procaterol, 180/10mcg X1, Budesonide/procaterol 180/10 mcg X 2, Albuterol HFA MDI 100mcg X2 - Asthma | Phase 2 | Completed | Intech Biopharm Ltd. | 39 | 2013-02-01 | 2015-06-03 |
| Multiple-dose Pharmacokinetics Study of "SYN006 HFA MDI" Administered Orally to Healthy Volunteers Budesonide/Procaterol 180/10 X 4 puffs - Asthma | Phase 1 | Completed | Intech Biopharm Ltd. | 16 | 2012-11-01 | 2015-06-03 |
| Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult. Budesonide, Procaterol - Asthma, Chronic Obstructive Pulmonary Disease (COPD) | Phase 1 | Completed | Intech Biopharm Ltd. | 24 | 2012-02-01 | 2015-06-03 |
Asthma (8) · Pulmonary Disease, Chronic Obstructive (5)
Budesonide (6) · Albuterol (4) · Fluticasone (2) · Formoterol Fumarate (2) · Procaterol (2) · Salmeterol Xinafoate (2) · Inhalation (1) · Methacholine Chloride (1) · Nebulizers and Vaporizers (1)
Taiwan (9) · China (1) · India (1)
W K Chang, M.D (2) · C M Perng, M.D (1) · C W Perng, M.D (1) · Chao-Hsien Chen, MD (1) · Pai-Chien Chou, MD, PhD (1) · Wei Hsiu Wu, MBA (1) · Wen K Chang, M.D. (1) · Wen-Kuei Chang, M.D. (1) · Wen-Kuei Chang, MD (1)