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Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

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ClinicalTrials.gov Identifier: NCT02281448
Recruitment Status : Completed
First Posted : November 2, 2014
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing with an oral once daily dose of 1200 mg of BIA 2-093

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Drug: Contraceptives, Oral, Combined Phase 1

Detailed Description:
Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions ─ once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers
Study Start Date : March 2005
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Treatment sequence A
oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
Drug: BIA 2-093
Drug: Contraceptives, Oral, Combined
Treatment sequence B
oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days
Drug: BIA 2-093
Drug: Contraceptives, Oral, Combined



Primary Outcome Measures :
  1. Cmax - Maximum Observed Plasma BIA 2-194 Concentration [ Time Frame: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily. ]
    Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period. ]
    Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

  2. Tmax [ Time Frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period. ]
    Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

  3. AUC0-t [ Time Frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period. ]
    AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pre-menopausal female;
  • Able and willing to give written informed consent;
  • Aged 18 to 40 years, inclusive;
  • Not pregnant or breast-feeding;
  • Body mass index (BMI) between 19 and 30 kg/m2, inclusive;
  • Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;
  • Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;
  • Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;
  • Negative test for drugs of abuse at screening;
  • Non-smoker or smokes less than 10 cigarettes or equivalent per day;
  • Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;
  • Negative pregnancy test at screening and admission to the first period.

Exclusion Criteria:

  • Had any contra-indication to the use of oral contraceptives;
  • Had experienced notable adverse events while on any oral contraceptive;
  • Had a history of alcoholism or drug abuse;
  • Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
  • Had acute gastrointestinal symptoms at the time of screening or admission to the first period;
  • Had a significant infection or inflammatory process at the time of screening or admission to the first period;
  • Had a relevant surgical history;
  • Had a relevant family history;
  • Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);
  • Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;
  • Consumed more than 14 units of alcohol a week;
  • Had participated in any clinical trial within 3 months prior to screening;
  • Had previously received BIA 2-093;
  • Had donated or received any blood or blood products within 2 months prior to screening;
  • Was unlikely to co-operate with the requirements of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281448


Locations
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Portugal
BIAL - Portela & Cª, S.A.
S. Mamede do Coronado, Portugal, 4045-457
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02281448    
Other Study ID Numbers: BIA-2093-114
First Posted: November 2, 2014    Key Record Dates
Results First Posted: December 3, 2014
Last Update Posted: December 3, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action