None listed
Conditions
Brief summary
This was a single centre, single dose, randomised, open, two-way, two-period, cross-over, two-stage bioequivalence study. The objective of the study was to assess the bioequivalence of the generic formulation of cysteamine bitartrate (test formulation Rec 0/0462: T) versus the marketed formulation (reference formulation Cystagon Registered Trademark: R), in healthy male and female volunteers. The two formulations T and R were orally administered as a single dose of 600 mg (i.e. a single dose of four 150 mg capsules), under fasting conditions, in two consecutive study periods, with a wash-out interval of at least 5 days between the two administrations. Each study subject underwent 6 visits.
Interventions
Test (T): Rec 0/0462, 150 mg cysteamine free base (as bitartate salt) immediate release capsules
Reference (R): Cystagon Registered Trademark, 150 mg cysteamine free base (as bitartrate salt) immediate release capsules
Two single doses of 600 mg of cysteamine base (as bitartrate salt) (one with Test and one with Reference formulations) were administered to each volunteer in two subsequent study periods, separated by wash-out intervals of 5 days.
Sponsors
CROSS SA (this is the full name of the primary sponsor)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1 Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: males/females of 18-45 year old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 beats/min, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study 6. Lifestyle: non-smokers or ex-smokers for at least 2 years 7. Contraception and fertility (females only): females of childbearing potential had to accept using a double reliable contraceptive method (one mechanical barrier method plus another one).
Exclusion criteria
1. 12 leads ECG (supine position): clinically significant (CS) abnormalities or: a. PQ interval < 120 msec or > 220 msec b. QRS duration < 75 msec or > 120 msec c. QTcB manual value > 440 msec (QTcB was measured manually only if QTcB > 440 msec) 2. Physical findings: CS abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: CS abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients and to penicillamine; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered may affect the outcome of the study 5. Diseases: significant history of renal, hepatic, gastrointestinal (in particular gastrointestinal bleeding or chronic gastrointestinal disease), cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study 6. Medications: medications, including over the counter (OTC) medications and herbal remedies, for 2 weeks before the start of the study, in particular current HIV or hepatitis treatment in the last three months. Hormonal contraceptives for females were allowed 7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that followed the last visit of the previous study and the first day of the present study 8. Blood donation: blood donations for 3 months before this study 9. Drug, alcohol, caffeine: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2010] or caffeine (>5 cups coffee/tea/day) abuse 10. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 11. Drug test: positive drug test at screening or Day -1 12. Alcohol test: positive alcohol breath test at Day -1 13. Pregnancy: pregnant or lactating women 14. Pregnancy test (all female subjects): positive pregnancy test at screening or Day -1
Outcome results
None listed