None listed
Conditions
Brief summary
The objective of Study IPX203-B13-02 is to characterize the pharmacokinetics of IPX203 and levodopa formulations in healthy subjects.
Interventions
IPX203 will be administered in a single-center, open-label, randomized, single-dose, 5-sequence, 5-treatment crossover study in healthy male adults. The treatment periods will be separated by a washout period of at least 7 days. All subjects will receive the following 5 treatments in a randomized sequence. All treatments will be administered with 240 mL of water to subjects in the fasted state.
Treatment A comprises 3 capsules and 2 tablets: 1 capsule of investigational formulations C0017, C001
IPX203 will be administered in a single-center, open-label, randomized, single-dose, 5-sequence, 5-treatment crossover study in healthy male adults. The treatment periods will be separated by a washout period of at least 7 days. All subjects will receive the following 5 treatments in a randomized sequence. All treatments will be administered with 240 mL of water to subjects in the fasted state. Treatment A comprises 3 capsules and 2 tablets: 1 capsule of investigational formulations C0017, C0019, C0022 and 2 tablets of carbidopa. Treatment B comprises 3 capsules and 2 tablets: 1 capsule of investigational formulations C0017, C0019, C0021 and 2 tablets of carbidopa. Treatment C comprises 3 capsules and 2 tablets: 1 capsule of investigational formulations C0017, C0020, C0021 and 2 tablets of carbidopa. Treatment D comprises 3 capsules: 1 capsule of investigational formulations C0013, C0016 and C0021. Treatment E comprises 1 tablet of Stalevo 100. Treatment E comprises 1 tablet of Stalevo 100. Treatment A regimen contains a total dose of 280mg Levodopa, 250 mg Entacapone and 50 mg of Carbidopa. Treatment B and C regimens each contain a total dose of 280mg equivalent Levodopa and 400 mg Entacapone formulated with different release characteristics, 50 mg of Carbidopa. Treatment D regimen contains a total dose of 256mg equivalent Levodopa, 400 mg Entacapone and 50 mg of Carbidopa. During each treatment period, subjects will remain at the clinical facility from the evening before dosing until approximately 8 h postdose for observation and PK sampling.
Sponsors
Impax Laboratories, Inc. Acting through its Impax Pharmaceuticals Division
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy males between 18 years and 65 years of age inclusive at the time of informed consent.
Exclusion criteria
Presence of a clinically significant disorder involving bleeding or hematologic or cardiovascular system abnormalities, acute infections, respiratory, renal, gastrointestinal, immunologic, hepatic, reproductive, endocrine, or neurologic system(s), or psychiatric disease (as determined by the Investigator) History of peptic ulcer disease or surgical procedure of the stomach, the small intestine, or the large intestine History of glaucoma Suspicious skin lesions or history of melanoma History of neuroleptic malignant syndrome (NMS) or nontraumatic rhabdomyolysis Subject has smoked or used tobacco products or nicotine products (patches, gums, etc.) within 60 days prior to Period 1 dosing; subjects does not agree to abstain from tobacco or nicotine products throughout the study.
Outcome results
None listed