A clinical trial to study the differences in blood concentrations of two formulations of the same drug administered to healthy adult subjects.

Phase 1

Completed

• Registration Number: CTRI/2009/091/000805
• Lead Sponsor: Adamas Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Be informed of the nature of the study and have provided written informed consent;

2. Be healthy males or females, of any race, at least 18 years old or the legal age of consent (whichever is greater) and less than 46 years of age at the time of the first dose of study medication;

3. Have a body mass index (BMI) >=18.5 and <30.0 kg/m2 and weigh 50-100 kg;

4. Be in good general health with no clinically relevant abnormalities based on the medical history, physical examination, clinical laboratory evaluations (hematology, clinical chemistry and urinalysis), and 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, would affect subject safety;

5. Be able to effectively communicate with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.

Exclusion Criteria

1. Any disease or condition that might affect drug absorption, metabolism, or excretion or compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, or gastrointestinal systems (unless deemed not clinically significant by the Principal Investigator and Sponsor);

2. Known or suspected hypersensitivity or allergic reaction to amantadine, rimantadine, memantine, or other therapeutics of similar chemical structure, or any of the components of ADS-5101 capsules;

3. Any medical or psychiatric condition that constitutes a contraindication or risk to taking the marketed product, including a history of epilepsy or seizure disorder (with the exception of febrile convulsions in childhood that have not recurred), suicide attempt or ideation, substance abuse, or angle-closure glaucoma;

4. If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose;

5. If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through to at least 4 weeks after the last dose of study drug, using one of the following: barrier methods (diaphragm or partner using condoms plus use of spermicidal jelly or foam, preferably double-barrier methods); oral or implanted hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner;

6. Blood loss or blood donation of >550 mL within 90 days before administration of the first dose of study drug;

7. Use of a drug therapy (including herbal preparations, e.g., St. John?s wort) known to induce or inhibit hepatic drug metabolism within 30 days prior to the first dose of study medication; );; or use of any medications [prescription or over-the-counter (OTC) other than allowable oral and implanted contraceptives], including antacids, multivitamins, nutritional supplements, and herbal preparations, within 14 days prior to the first dose of study drug, unless approved by the Sponsor;

8. Past or current history or evidence of drug or alcohol abuse, use of any recreational drugs within 3 months prior to the first dose of study drug, and/or a positive screen for substances of abuse at screening or pre-dose;

9. Consumption of alcohol, caffeine and/or xanthine products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas), or tobacco or nicotine use, within 24 hours prior to the first dose of study drug;

10. Have smoked >5 cigarettes per day or equivalent nicotine-containing products (on average) over the last 3 months; unable to abstain from smoking for the duration of the study;

11. Ingestion of grapefruit or grapefruit juice within 48 hours prior to dose administration;

12. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;

13. Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) prior to the first dose of study medication;

14. Receipt of an investigational immunomodulator or monoclonal antibody within 180 days (or 5 half-lives, whichever is longer) prior to the first dose of study medication;

15. A drastic change in diet, for whatever reason (e.g., low sodium, recent conversion to vegetarian diet, low calorie) in the 4 weeks prior to receiving the study medication; in any such case,

Study & Design

• Study Type: BA/BE
• Study Design: Not specified