Primary objective 1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulation Secondary objective 1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…
ID
Bron
Aandoening
Seksueel functioneren, Seksuele disfunctie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
90% CI ratio for both AUC0-inf and Cmax
Achtergrond van het onderzoek
A total of 18 subjects receive the investigational drug. During the 2 experimental days (where bloodsampling for PK analysis will take place), subjects receive Lybridos under Fed and Fasted conditions in random order. Subjects visit the site à total of 8 times: 1 screening visit, 1 experimental day for two times in a crossover (consisting of an admission,day 1 and day 2) and 1 final follow up visit.
Doel van het onderzoek
Primary objective
1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulation
Secondary objective
1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed conditions
Onderzoeksopzet
A total of 18 subjects receive the investigational drug. During the 2 experimental days (where bloodsampling for PK analysis will take place), subjects receive Lybridos under Fed and Fasted conditions in random order. Subjects visit the site à total of 8 times: 1 screening visit, 1 experimental day for two times in a crossover (consisting of an admission,day 1 and day 2) and 1 final follow up visit.
Onderzoeksproduct en/of interventie
Lybridos 2 gifts
Publiek
Louis Armstrongweg 78
J. Gerritsen
Almere 1311 RL
The Netherlands
j.gerritsen@emotionalbrain.nl
Wetenschappelijk
Louis Armstrongweg 78
J. Gerritsen
Almere 1311 RL
The Netherlands
j.gerritsen@emotionalbrain.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Provision of informed consent
2. Females between 18 and 55 years of age (both inclusive)
3. Healthy based on medical history, physical examination (including vital signs), electrocardiogram, laboratory values
4. Body mass index (BMI) ≥18 kg/m2 and ≤ 30 kg/m2
5. Venous access sufficient to allow blood sampling as per protocol
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Cardiovascular conditions
1. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
2. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure< 50 mmHg
Gynaecological and obstetric conditions
3. Use of oral contraceptives containing anti-androgens (e.g. crypteron acetate) or anti (androgenic) progestogens (drosperidone, dienogest, chlormadinone acetate and norgestrel)
4. Use of any hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen
5. Pregnancy (note: an urine pregnancy test will be performed in all women prior to the administration of study medication)
6. Lactating or delivery in the previous 6 months
7. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night contraceptive sweating) in combination with elevated FSH levels (>40 IU/L) for women age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (>40 IU/L) and/or vasomotor symptoms)
General
8. Use of any drugs from two weeks prior to admission to the research unit until the follow-up visit, except for allowed oral contraceptives and pain relief (e.g. paracetamol up to 1.5 g per day)
9. Known or suspected hypersensitivity to any of the components of the formulation
10. Liver function tests (i.e., alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) significantly above the upper limit of normal (ULN) at repeated measures
11. Any clinically significant history or any other disease or disorder- gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic as judged by the medical investigator
12. Smoking
13. Unwilling or unable to refrain from consuming grapefruit juice, star fruit and St. Johns Wort 24 hours before and after intake of medication
14. Current regular use of any illicit drugs or history of excessive drinking within 3 months prior to admission to the research unit and/or unwilling or unable to refrain from products containing alcohol from 24 hours before admission and during the stay in the research unit
15. Donation of blood within 3 months prior to admission to the research unit
16. Positive serology test for hepatitis B serum antigen (HBsAg), anti-hepatitis A virus (HAV) (IgM), anti-hepatitis C virus (HCV) or anti human immunodeficiency virus (HIV) 1+2
17. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason
18. Participation in any clinical study within 1 month prior to the expected date of enrolment into the study.
19. Employees of the sponsor or CRO involved in the study
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4717 |
NTR-old | NTR4862 |
CCMO | NL50357.056.14 |
OMON | NL-OMON41098 |