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Amphastar Pharmaceuticals, Inc.

AMPH
Healthcare|Drug Manufacturers - Specialty & Generic|US
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Clinical Trials (21)

TrialConditionsPhaseStatusEnrollmentDesignDrug
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
Pharmacokinetics, Epinephrine
P4
Completed28RCT, Single-blind—
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
Pharmacokinetics, Pharmacodynamics
P2P3
Completed62RCT, Double-blindI004, NovoLog
NCT01357642
Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
Asthma
P3
Completed373RCT, Double-blindEpinephrine inhalation aerosol, Placebo, epinephrine inhalation aerosol
NCT00634829
Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction
Asthma, Bronchospasm
P3
Terminated24RCT, Double-blindalbuterol (Armstrong Albuterol HFA), Albuterol Sulfate (Provenetil-HFA), Placebo-HFA
NCT00634517
4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma
Asthma
P3
Terminated48RCT, Double-blindArmstrong Albuterol Sulfate Inhalation Aerosol, Albuterol Sulfate Inhalation Aerosol
NCT01737905
Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma
Asthma
P3
Completed28RCT, Double-blindEpinephrine HFA-MDI (E004), Placebo-HFA
NCT01460511
Evaluation of Efficacy and Safety of E004 in Children With Asthma
Asthma
P3
Completed70RCT, Double-blindE004 (Epinephrine Inhalation Aerosol) HFA-MDI, Placebo-HFA
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
Pharmacokinetics, Pharmacodynamics
P2P3
Completed69RCT, Double-blindI004, NovoLog
NCT01476904
Safety Study in Adolescent and Adult Patients With Asthma
Asthma
P3
Completed208RCT, Double-blindPlacebo, Primatene Mist, Epinephrine inhalation
NCT00635505
Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
Asthma
P3
Terminated300RCT, Double-blindalbuterol HFA (Armstrong's), albuterol HFA (Proventil HFA), HFA placebo
NCT01737892
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
Asthma
P1P2
Terminated21RCT, Single-blindArm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC
NCT01174732
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
Asthma, Bronchospasm
P2
Completed26RCT, Double-blindalbuterol inhalation powder, albuterol inhalation powder, albuterol inhalation powder, albuterol inhalation powder, Placebo, albuterol inhalation aerosol, albuterol inhalation aerosol
NCT01689363
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
Allergic Skin Reaction
P2
Completed253RCT, Double-blindHyaluronidase, Histamine, Saline
NCT02210806
Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
Asthma
P2
Completed22RCT, Double-blindA006 DPI, A006 DPI, Proventil® MDI, Proventil® MDI
NCT01188577
Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
Asthma, Bronchospasm
P1P2
Completed23RCT, Double-blindEpinephrine Inhalation Aerosol, HFA, Epinephrine Inhalation Aerosol
NCT01189396
Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006
Asthma, Bronchospasm
P2
Completed27RCT, Double-blindA006, Placebo DPI, Proventil-HFA
NCT01581177
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
Asthma
P2
Completed23RCT, Double-blindAlbuterol DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh, Placebo DPI, Albuterol MDI 90 mcg/inh
NCT01143051
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
Asthma
P1P2
Completed24RCT, Double-blindepinephrine inhalation aerosol, epinephrine inhalation aerosol, epinephrine inhalation aerosol
NCT01255709
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
Asthma
P2
Completed24RCT, Double-blindArm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA, Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
NCT02271334
Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
Asthma
P2
Completed22RCT, Double-blindA006 DPI, A006 DPI, Proventil® MDI, Proventil® MDI
NCT01025648
Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.
Asthma
P1P2
Terminated9RCT, Double-blindE004 (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