Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects

NCT00915174 | Completed Phase 1

• 1 other identifier: MRZ 92579/TI/1005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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®)

Conditions

Healthy

Keywords

drug-drug interaction study

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Neramexane DRUG

25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

AAIharma Deutschland GmbH & Co. KG

Neu-Ulm, Bavaria, 89231, Germany

Location

MeSH Terms

Interventions

neramexane

Study Officials

• Medical Expert

  Merz Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 5, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 6, 2011

Record last verified: 2011-05

Locations

DE (1)