A randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of buspirone after a single oral administration of Lybridos in healthy female subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

1. Provision of written informed consent
2. Females between 18 and 55 years of age (both inclusive)
3. Healthy based on medical history, physical examination, electrocardiogram, laboratory values and vital signs
4. Body mass index (BMI) >=18 kg/m2 and <= 30 kg/m2
5. Venous access sufficient to allow blood sampling as per protocol;

Exclusion Criteria

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
3. Use of oral contraceptive containing anti-androgens (e.g. cyproteron) or anti(androgenic) progestogens (drospirone, dienogest, chlormadinone acetate and norgestrel)
4. Use of any or 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 from age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms)
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., ALT, AST and bilirubin) significantly above the upper limit of normal at repeated measures
11. Any clinically significant history of 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 HBsAg, anti HAV (IgM), anti HCV or anti 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic<br /><br>90% CI ratio for both AUC0-inf and Cmax</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic<br /><br>Difference in Tmax and tlag<br /><br>and<br /><br>- Area under the concentration time curve (AUC)<br /><br>- Peak exposure (Cmax)<br /><br>- Time to peak exposure (Tmax)<br /><br>- Lag time (tlag)<br /><br>- Terminal elimination half-life (t*)<br /><br><br /><br>Safety<br /><br>A. Nature, frequency and severity of AEs<br /><br>B. Vital signs and 12-lead ECG<br /><br>C. Safety laboratory tests (urinalysis, haematology, biochemistry)</p><br>