A single dose, open-label, randomised, cross-over bioequivalence study in healthy young men comparing two formulations of escitalopram: the conventional immediate release tablet and the to be marketed orally dispersible tablet

Completed

Conditions: depression
10027946
depressive disorder

Registration Number: NL-OMON32586

Lead Sponsor: undbeck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. The subject is able to read and understand the Subject Information Sheet.
2. The subject and the physician have signed a study-specific Informed Consent Form. No study-related procedures, including any screening procedures, may be performed before the physician has obtained written informed consent from the subject.
3. The subject is a man.
4. The subject is >=18 years of age and <=55 years of age.
5. The subject has a BMI >=19 kg/m2 and <=29 kg/m2.
6. The subject has a resting pulse and heart rate (as read on the ECG) >=51 bpm and <=100 bpm. For subjects in good physical condition, the lower limit is >=45 bpm.
7. The subject has a resting systolic blood pressure >=91 mmHg and <=140 mmHg and a resting diastolic blood pressure >=51 mmHg and <=90 mmHg. At the Screening Visit or at the Baseline Visit if not assessed at the Screening Visit, an out-of-range resting systolic blood pressure may be repeated once if a medically valid reason is present, for example, white coat hypertension or coming from low outdoor temperatures. The medically valid reason should be documented and signed by the investigator.
8. The subject has an orthostatic blood pressure change <20 mmHg (based on the difference between supine and standing systolic blood pressure).
9. The subject has clinical laboratory test values within the reference ranges. Borderline values may be accepted if they are, in the opinion of the investigator, clinically insignificant.
10. The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.

Exclusion Criteria

1. The subject has taken disallowed medication within 1 week prior to the first dose of IMP (or within 5 half-lives prior to inclusion for any medication ingested, whichever is longer). Disallowed medication is any prescribed medication or over-the-counter (OTC) medication as well as any herbal medicine known to interfere with the metabolic CYP pathways, such as St. John*s Wort. Subjects who have taken any non-prescribed systemic or topical medication may still be entered into the study if, in the opinion of the investigator, the medication will not interfere with the study procedures, study results, or compromise safety.
2. The subject has a significant history of drug or alcohol abuse, defined as an alcohol intake greater than 21 units per week for men, or a history of drug abuse within the last 6 months, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits.
3. The subject has taken any investigational products within 3 months prior to the first dose of IMP.
4. The subject has previously been dosed with IMP in this study (excluding subjects who have been asked to participate in a crossover cohort of the study).
5. The subject has known hypersensitivity to any of the IMPs or their excipients.
6. The subject has a history of severe drug allergy or hypersensitivity.
7. The subject has a history of or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
8. The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of IMP.
9. The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or nonperipheral vascular surgery within 6 months prior to the first dose of IMP.
10. The subject has any concurrent illness that may affect the particular target or metabolism of the IMP.
11. The subject has had a clinically significant illness within 4 weeks prior to the first dose of IMP.
12. The subject has had surgery or trauma with significant blood loss (>500mL) within the last 3 months prior to the first dose of IMP.
13. The subject has donated blood within 3 months prior to the first dose of IMP.
14. The subject has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).
15. The subject is a regular smoker or regularly uses other nicotine containing products (for example, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, inhalers). Ex-smokers should have ceased smoking at least 1 months prior to the first dose of IMP.
16. The subject has tested positive after the Screening Visit or at the Safety Baseline Visit for drugs of abuse (opiates, methadone, cocaine, amphetamines (including ecstasy), barbiturates, benzodiazepines and cannabinoids).
17. The subject*s QTc (Bazett*s or Fridericia*s correction) is >450 ms (at the Screening Visit or at the Safety Baseline Visit) as read on the printout of the ECG produced by the ECG equipment and evaluated by the investigator. At the Screening Visit or at the Baseline