Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015108-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a bioequivalence study, which is a regulatory requirement to ensure comparable in vivo performance, i.e. similarities in terms of safety and efficacy, after administration of two different dosage forms of escitalopram.
All subjects will receive three separate dosages of 20 mg escitalopram, which are 2 x 10 mg of the conventional dosage form (Treatment A) and 2 x 10 mg of the new dosage form being tested (Treatment B) and 1 x 20 mg of the new dosage form being tested (Treatment C). Test treatments B and C will each be compared to Treatment A, which is the active comparator (reference formulation).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Conventional escitalopram |
|
| Treatment B | Experimental | Escitalopram test treatment B |
|
| Treatment C | Experimental | Escitalopram test treatment C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 2 x 10 mg, single dose |
| |
| Escitalopram |
| Measure | Description | Time Frame |
|---|---|---|
| To show bioequivalence on the basis of the area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of two different dosage forms of escitalopram | The new dosage form being tested will be administered both as 2 x 10 mg and as 1 x 20 mg | From the day of dosing up to 7 days in each dosing period |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of the administration of the two dosage forms | Safety and tolerability parameters such as adverse advents, clinical safety laboratory tests and vital signs will be summarised using descriptive statistics | Baseline + from the day of dosing up to 7 days in each dosing period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NL001 | Leiden | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21999886 | Result | Nilausen DO, Zuiker RG, van Gerven J. The perception and pharmacokinetics of a 20-mg dose of escitalopram orodispersible tablets in a relative bioavailability study in healthy men. Clin Ther. 2011 Oct;33(10):1492-502. doi: 10.1016/j.clinthera.2011.09.012. Epub 2011 Oct 13. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
2 x 10 mg, single dose |
|
| Escitalopram | Drug | 1 x 20 mg, single dose |
|
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |