A randomized, cross-over controlled study to compare the pharmacokinetic profiles of sublingual administered testosterone solution followed by a buspirone tablet, versus sublingual testosterone and buspirone combined in one tablet in healthy premenopausal wome

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Provision of written informed consent
2. Female 18-35 years of age (inclusive)
3. Healthy based on medical history, physical examination, 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

Cardiovascular conditions
1. Any underlying cardiovascular condition, including unstable angina pectoris
2. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg.
3. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg;Gynecological and obstetric conditions
4. Use of oral contraceptive containing anti-androgens (e.g. Crypteron acetate) or (anti) androgenic progesteron (drospirone, dienogest, chlormadinone acetate and norgestrel)
5. Use of oral contraceptive containing 50 µg estrogen or more
6. Pregnancy or intention to become pregnant during this study (Note: An urine pregnancy test will be performed in all women prior to the administration of study medications.)
7. Lactating or delivery in the previous 6 months
8. Unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
9. Subjects with a perimenopausal hormonal status (follicle-stimulating hormone>30);Other medical conditions
10. Liver- and/or renal insufficiency
11. Current clinically relevant endocrine disease
12. Current clinically relevant neurological disease which, in the opinion of investigator, would compromise the validity of study results, or which could form a contraindication for buspirone and/or testosterone use
13. (A history of) hormone-dependant malignancy;Psychological/psychiatric factors
14. A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject*s participation in the study; mild or moderate alcohol consumption is allowed but must be stopped 24 hours before the admission period. Recreational drug use is not allowed beginning 3 weeks before the start of the admission period until follow up. Smokers are not allowed to participate.;Concomitant medication
15. Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir)
16. Subjects who are taking CYP3A4-inducers (eg, fenytoïne, fenobarbital, st Johns Wort, rifampicine)
17. Use of serotonergic drugs (eg, trazodon, fluvoxamine)
18. Use of testosterone therapy within 6 months before study entry
19. Use of any other medication that interferes with study medication (eg, monoamine oxidase (MAO) inhibitors (includes classic MAO inhibitors and linezolid), calcium channel blockers (eg, diltiazem and verapamil), use of corticosteroids);Drug/food interaction
20. Consumption of grapefruit or grapefruit-containing foods throughout the duration of the study;General
21. Illiteracy, unwillingness, or inability to follow study procedures
22. Any other clinically significant abnormality or condition which, in the opinion of investigator, might interfere with the participant*s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for buspirone and/or testosterone use.
23. Participation in any other clinical drug study in the previous 3 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Cmax of total testosterone (F2 >= 75% of Cmax F1);<br /><br>• Cmax of free testosterone ( F2 >= 75% of Cmax F1);<br /><br>• Cmax of buspirone (F2 >= 75% of Cmax F1);<br /><br><br /><br>• AUC0-1590 of total testosterone (F2 >= 75% of AUC0-1590 F1);<br /><br>• AUC0-1590 of free testosterone (F2 >= 75% of AUC0-1590 F1);<br /><br>• AUC0-infinity of buspirone (F2 >= 75% of AUC0-infinity F1);</p><br>

Secondary Outcome Measures