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Primary:
To assess the effects of repeated dose of Neramexane on the steady-state pharmacokinetics of Drospirenone [DRSP] and Ethinyl Estradiol [EE]
Secondary:
To assess safety and tolerability of concomitant repeated dose treatments of Neramexane and a fixed-combinational DRSP- and EE-containing oral contraceptive [OC] (Yasmin®)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neramexane | Drug | 25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve within a dose interval (AUC, 0-tau) and Maximum Plasma Concentration at Steady State (Cmax) of Drospirenone (DRSP) and Ethinyl Estradiol (EE) | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | Merz Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AAIharma Deutschland GmbH & Co. KG | Neu-Ulm | Bavaria | 89231 | Germany |
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| ID | Term |
|---|---|
| C114144 | neramexane |
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