Amphastar Pharmaceuticals, Inc. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-04-06: Study NCT07560150; Company role Lead sponsor; Phase Phase 2, Phase 3; Status Completed.
- 2022-08-22: Study NCT05539872; Company role Lead sponsor; Phase Phase 2, Phase 3; Status Completed.
- 2019-12-09: Study NCT04207840; Company role Lead sponsor; Phase Phase 4; Status Completed.
- 2014-08: Study NCT02271334; Company role Lead sponsor; Phase Phase 2; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-04-06 | NCT07560150 Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers | Lead sponsor | Phase 2, Phase 3 | Completed | Pharmacokinetics; Pharmacodynamics; Insulin Aspart | 62 | 2026-06-25 |
| 2022-08-22 | NCT05539872 Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers | Lead sponsor | Phase 2, Phase 3 | Completed Results posted | Pharmacokinetics; Pharmacodynamics | 69 | 2023-01-30 |
| 2019-12-09 | NCT04207840 Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals | Lead sponsor | Phase 4 | Completed Results posted | Pharmacokinetics; Epinephrine; Albuterol; Asthma; Anaphylaxis | 28 | 2019-12-23 |
| 2014-08 | NCT02271334 Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers | Lead sponsor | Phase 2 | Completed | Asthma | 22 | 2015-03 |
| 2014-07 | NCT02210806 Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation | Lead sponsor | Phase 2 | Completed | Asthma | 22 | 2014-10 |
| 2012-11 | NCT01737892 Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults | Lead sponsor | Phase 1, Phase 2 | Terminated | Asthma | 21 | 2012-11 |
| 2012-10 | NCT01737905 Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma | Lead sponsor | Phase 3 | Completed | Asthma | 28 | 2013-12 |
| 2012-09 | NCT01689363 Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP) | Lead sponsor | Phase 2 | Completed Results posted | Allergic Skin Reaction | 253 | 2012-12 |
| 2012-04 | NCT01581177 Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation | Lead sponsor | Phase 2 | Completed | Asthma | 23 | 2012-08 |
| 2011-11 | NCT01476904 Safety Study in Adolescent and Adult Patients With Asthma | Lead sponsor | Phase 3 | Completed | Asthma | 208 | 2012-07 |
| 2011-10 | NCT01460511 Evaluation of Efficacy and Safety of E004 in Children With Asthma | Lead sponsor | Phase 3 | Completed | Asthma | 70 | 2012-07 |
| 2011-07 | NCT01357642 Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients | Lead sponsor | Phase 3 | Completed | Asthma | 373 | 2011-12 |
| 2010-12 | NCT01255709 Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS | Lead sponsor | Phase 2 | Completed | Asthma | 24 | 2011-01 |
| 2010-08 | NCT01188577 Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Asthma; Bronchospasm; Wheezing; Shortness of Breath | 23 | 2011-01 |
| 2010-07 | NCT01189396 Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006 | Lead sponsor | Phase 2 | Completed | Asthma; Bronchospasm; Chronic Obstructive Pulmonary Disease (COPD) | 27 | 2011-01 |
| 2010-07 | NCT01174732 Dose-Ranging Study of A006 DPI, in Adult Asthma Patients | Lead sponsor | Phase 2 | Completed | Asthma; Bronchospasm | 26 | 2011-01 |
| 2010-01 | NCT01143051 Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Asthma | 24 | 2010-06 |
| 2009-12 | NCT01025648 Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients. | Lead sponsor | Phase 1, Phase 2 | Terminated | Asthma | 9 | 2009-12 |
| 2008-03 | NCT00634517 4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma | Lead sponsor | Phase 3 | Terminated | Asthma | 48 | 2008-12 |
| 2008-02 | NCT00634829 Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction | Lead sponsor | Phase 3 | Terminated | Asthma; Bronchospasm | 24 | 2008-10 |
| 2007-09 | NCT00635505 Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients | Lead sponsor | Phase 3 | Terminated | Asthma | 300 | 2008-08 |
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