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Clinical trials
catalyst calendar across sponsors →Studies where AMPH is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
21 interventional · 5 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| 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 VolunteersNCT07560150Maximum Serum Insulin Aspart Concentration, CIAmaxRandomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: I004, NovoLog | Pharmacokinetics, Pharmacodynamics, Insulin Aspart | 62 | 2026-06-22actual | 2026-07-22 |
| 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 VolunteersNCT05539872results2026-03-05Maximum Serum Insulin Aspart Concentration, CIAmaxRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: I004, NovoLog | Pharmacokinetics, Pharmacodynamics | 69 | 2023-01-29actual | 2026-03-05 |
| 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 IndividualsNCT04207840results2021-03-30C[Max], Maximum Plasma Concentration of Albuterol or EpinephrineRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Combination product: Epinephrine (0.125 mg/inhalation), Epinephrine Injection Auto-Injector (0.3mg/0.3mL), Albuterol Sulfate (0.09 mg/inhalation) | Pharmacokinetics, Epinephrine, Albuterol, Asthma, Anaphylaxis | 28 | 2019-12-20actual | 2021-03-30 |
| Evaluation of Pharmacokinetics and Safety of A006 in Healthy VolunteersNCT02271334Area Under the Curve of Drug Concentration versus Time (AUC[0-t])Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: A006 DPI, A006 DPI, Proventil® MDI, Proventil® MDI | Asthma | 22 | Oct 2014actual | 2017-04-19 |
| Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety EvaluationNCT02210806Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Percentage Change (∆%FEV1) from the Same-Day Pre-Dose BaselineRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: A006 DPI, A006 DPI, Proventil® MDI, Proventil® MDI · Other: Placebo DPI | Asthma | 22 | Sep 2014actual | 2017-04-19 |
| Evaluation of Efficacy and Safety for Single Dose of E004 in Children With AsthmaNCT01737905Bronchodilator effectRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Epinephrine HFA-MDI (E004), Placebo-HFA | Asthma | 28 | Mar 2013actual | 2016-03-11 |
| Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)NCT01689363results2017-01-20Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)Randomized · Triple-masked · Screening | Phase 2 | Completed | Drug: Hyaluronidase, Histamine, Saline | Allergic Skin Reaction | 253 | Nov 2012actual | 2017-01-20 |
| Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy AdultsNCT01737892Calculation and Comparison of relative Bioavailability of EpinephrineRandomized · Single-masked · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: unable to validate analytical method | Drug: Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC | Asthma | 21 | Nov 2012actual | 2016-03-17 |
| Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety EvaluationNCT01581177Change in FEV1 Area Under the Curve (AUC) versus placeboRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Albuterol DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh, Placebo DPI, Albuterol MDI 90 mcg/inh | Asthma | 23 | Jul 2012actual | 2017-05-19 |
| Safety Study in Adolescent and Adult Patients With AsthmaNCT01476904Adverse EventsRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Primatene Mist, Epinephrine inhalation | Asthma | 208 | Apr 2012actual | 2017-02-13 |
| Evaluation of Efficacy and Safety of E004 in Children With AsthmaNCT01460511Primary Efficacy Endpoint AUC of FEV1's relative changeRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI, Placebo-HFA | Asthma | 70 | Mar 2012actual | 2018-07-31 |
| Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma PatientsNCT01357642Change in Area Under the Curve (AUC) versus placeboRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Epinephrine inhalation aerosol, Placebo, epinephrine inhalation aerosol | Asthma | 373 | Nov 2011actual | 2016-03-11 |
| Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICSNCT01255709Pharmacokinetics including maximum concentration and area under the curveRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA, Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) | Asthma | 24 | Jan 2011actual | 2016-03-17 |
| Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006NCT01189396Bronchodilatory efficacy after the escalating and cumulative-doses, up to 1,440 mcg.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: A006, Placebo DPI, Proventil-HFA | Asthma, Bronchospasm, Chronic Obstructive Pulmonary Disease (COPD) | 27 | Dec 2010actual | 2017-07-02 |
| Dose-Ranging Study of A006 DPI, in Adult Asthma PatientsNCT01174732AUCRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: albuterol inhalation powder, albuterol inhalation powder, albuterol inhalation powder, albuterol inhalation powder, Placebo, albuterol inhalation aerosol, albuterol inhalation aerosol | Asthma, Bronchospasm | 26 | Oct 2010actual | 2017-04-19 |
| Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of PharmacokineticsNCT01188577results2014-10-24Baseline Concentration (C0) of Total EpinephrineRandomized · Triple-masked · Treatment | Phase 1/2 | Completed | Drug: Epinephrine Inhalation Aerosol, HFA, Epinephrine Inhalation Aerosol | Asthma, Bronchospasm, Wheezing, Shortness of Breath | 23 | Sep 2010actual | 2017-07-25 |
| Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy VolunteersNCT01143051results2014-07-15Baseline Concentration (C0) of Labeled Epinephrine Total EpinephrineRandomized · Triple-masked · Treatment | Phase 1/2 | Completed | Drug: epinephrine inhalation aerosol, epinephrine inhalation aerosol, epinephrine inhalation aerosol | Asthma | 24 | Jun 2010actual | 2018-09-25 |
| Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.NCT01025648The AUC of post-dose FEV1 percentage changes (Δ%) from the Pre-dose baseline. The primary analysis of the primary endpoint is the difference of Δ% FEV1, compared between the E004 treatment arms (T1, T2, T3 and T4) and the Placebo control (Arm P).Randomized · Triple-masked · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Optimization of protocol | Drug: E004 (epinephrine inhalation aerosol), 90 mcg/actuation, E004 Placebo, E004 (epinephrine inhalation aerosol), 125 mcg, E004 (epinephrine inhalation aerosol), 220 mcg, epinephrine inhalation aerosol, CFC propelled, E004 (epinephrine inhalation aerosol), 160 mcg | Asthma | 9 | Dec 2009actual | 2018-05-16 |
| 4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric AsthmaNCT00634517The primary endpoint for efficacy evaluation is to obtain the ratio of the geometric mean of area under the curve of change in FEV1%versus time for pediatric patients using the study drug to the active reference drug.Randomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: IND voluntarily withdrawn, without prejudice | Drug: Armstrong Albuterol Sulfate Inhalation Aerosol, Albuterol Sulfate Inhalation Aerosol | Asthma | 48 | Dec 2008actual | 2013-07-15 |
| Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced BronchoconstrictionNCT00634829The maximum percentage fall in FEV1, from the Pre-Exercise FEV1, between Albuterol-HFA and Placebo-HFA.Randomized · Quadruple-masked · Prevention | Phase 3 | Terminatedsponsor's stated reason: IND voluntarily withdrawn, without prejudice | Drug: albuterol (Armstrong Albuterol HFA), Albuterol Sulfate (Provenetil-HFA), Placebo-HFA | Asthma, Bronchospasm | 24 | Oct 2008actual | 2013-07-15 |
| Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic PatientsNCT00635505The primary endpoint is the bronchodilator effect expressed as the mean area under the curve (AUC) of FEV1 (% change from Same-Day Baseline FEV1) versus time.Randomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: IND voluntarily withdrawn, without prejudice | Drug: albuterol HFA (Armstrong's), albuterol HFA (Proventil HFA), HFA placebo | Asthma | 300 | Aug 2008actual | 2013-07-15 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19