Healthy
Conditions
Keywords
drug-drug interaction study
Brief summary
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®)
Interventions
DRUGNeramexane
25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult female subject of child bearing potential (including subject with tubal ligation), white origin, who is able to read, to write and fully understand German language * Aged 18 to 45 years (both inclusive) * BMI of 18-28 kg/m2 and a body weight of 50-90 kg (both inclusive) * The subject is required * To have taken a DRSP/EE- containing OC for at least two dosing cycles * To agree using reliable non hormonal birth control methods from Day -1 of study Period 1 until the Final Examination (e.g. non-hormonal IUD, double barrier method \[e.g. condom with spermicide or diaphragm with spermicide\], sexual abstinence). Women with tubal ligation or sterilized partner do not need an additional birth control method * Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
Exclusion criteria
* History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/ Amantadine and their derivatives * Hypersensitivity to Quinine * History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used study medications (Neramexane, Yasmin®, Placebo) or tool substance * History of clinically relevant allergy or known hypersensitivity to DRSP/EE * Clinically relevant findings on the mammae or genital examination, PAP smear ≥ III * Any contraindications against the oral contraceptive: * present or past venous thromboses (deep vein thrombosis, pulmonary embolism); * present or past arterial thromboses (e.g. myocardial infarction) or their prodromal stages (e.g. angina pectoris and transitory ischaemic attack); * present or past cerebrovascular insult; * presence of a serious risk factor or several risk factors for an arterial thrombosis: diabetes mellitus with vascular changes, severe hypertension, severe lipid metabolism disturbance; * known or suspected genetic or acquired predisposition for venous or arterial thromboses like APC resistance, * known or suspected genetic lack of antithrombin III, lack of protein C, lack of protein S, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulants); * present or past pancreatitis if this is accompanied by severe hypertriglyceridaemia; * present or past severe hepatic disease as long as the liver function tests have not normalized; * severe renal insufficiency or acute renal failure; * present or past hepatic tumors (benign or malign); * known or suspected sexual hormone dependent, malign tumors (e.g. of the genital organs or the mamma); * diagnostic not clarified vaginal bleedings; * anamnesis of migraine with focal neurologic symptoms; * known hereditary angioedema * Exposure to another investigational agent within the last two months before Day 1 of Period 1
Design outcomes
Primary
| Measure | 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 |
Countries
Germany
Outcome results
None listed