Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects (NCT06107205) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects
United States29 participantsStarted 2023-11-07
Plain-language summary
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.The objective is To characterize the bioequivalence、safety and tolerability of TTYP01 tablets and Radicava® injection or Radicava ORS®in healthy adult subjects under fasted conditions.In this study, 30 healthy adult subjects will receive TTYP01, or Radicava, orRadicava ORS in each period according to the randomization sequence.
Who can participate
Age range20 Years – 45 Years
SexALL
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Inclusion criteria
✓. Informed consent signed and dated by the subject
✓. Healthy male and female subjects of any ethnic and racial origin, aged 20 to 45 years, inclusive
✓. Female subjects who:
✓. Male subjects who are sexually active and whose partners are females of child-bearing potential, even if surgically sterilized (ie, status post vasectomy), who:
✓. Body mass index (BMI) of 19 to 30 kg/m2 (inclusive) (BMI = weight (kg)/(height \[m\])2)
✓. Non-smokers (defined as having abstained from tobacco- or nicotine-containing products \[eg, cigarettes, chewing tobacco, snuff, nicotine patches, and electronic cigarettes\] in the 6 months prior to screening), stable light smokers, and ex-smokers will be included. Stable light and ex-smokers are defined as follows: "A light smoker is defined as someone smoking ≤5 cigarettes per day; an ex-smoker is someone who has completely stopped smoking for at least 3 months."
✓. In good health, as determined by the investigator at screening and confirmed at check-in, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
✓. Subjects must be willing to understand and able to comply with all research procedures and restrictions, and are able to communicate effectively with researchers.
Exclusion criteria
✕. History of any hypersensitivity or allergic reaction to active ingredients or excipients of the study drugs (eg, known allergy to bisulfite containing foods such as bottled lemon juice, grape juice, canned fruits, wine, jam, jelly, etc.)
What they're measuring
1
PK Parameters-Area under the plasma concentration-time curve (AUC0-inf) from time 0 extrapolated to infinity of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Timeframe: up to 48 hours each postdose
2
PK Parameters- AUC from time 0 to the last measurable non-zero concentration（AUC0-t）of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Timeframe: up to 48 hours each postdose
3
PK Parameters - Maximum observed concentration （Cmax） of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
✕. Positive test result for infectious diseases at screening or baseline, including human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody, and syphilis antibody
✕. Positive alcohol test at screening or baseline, or has a history of alcohol abuse (alcohol consumption in excess of 1 standard drink per day for women and 2 standard drinks per day for men; whereby 1 standard drink is equivalent to 12 oz beer \[5% alcohol\], 5 ounces of wine \[12% alcohol\], and 1.5 ounces of 80 proof \[40% alcohol\])
✕. Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study; or have a positive pregnancy test result at screening or check-in
✕. Any abnormal physical examination, vital sign, ECG, or laboratory values at screening or check-in that are considered clinically significant by the investigator
✕. Special dietary requirements or restrictions and cannot follow a uniform diet
✕. History of febrile illness or evidence of active infection within 14 days prior to the first dose
✕. Any subject with SARS-CoV-2 infection, based on a rapid test or positive polymerase chain reaction for SARS-CoV-2, or subjects who received the SARS-CoV-2 vaccine within 1 month prior to the first dosing, or plans to have the vaccine within 1 month after the last dose