Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Plasma BIA 2-194 Concentration
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: BIA 2-093 (Drug)
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
干预措施: Contraceptives, Oral, Combined (Drug)
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
干预措施: BIA 2-093 (Drug)
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
干预措施: Contraceptives, Oral, Combined (Drug)
结局指标
主要结局
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
时间窗: 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.
次要结局
- Tmax(pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.)
- Cmax(pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.)
- AUC0-t(pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.)