NL-OMON37007已完成不适用
Bioequivalence of Orfadin suspension 4 mg/mL compared to Orfadin capsules 10 mg, and the effect of food on the bioavailability of the suspension. An open-label, randomized, cross-over, single-dose study in healthy volunteers. - Bioequivalence of nitisinone oral capsule formulation
Swedish Orphan International0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •healthy male subjects
- •18-55 yrs, inclusive
- •BMI: 18.5-30.0 kg/m2, inclusive
- •smoking <<= 10 cigarettes per day
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor > 50 mL within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
研究者
相似试验
已完成
不适用
A study to evaluate the bioequivalence of Orfadin capsules 20 mg compared to Orfadin capsules 10 mg. An open-label, randomized, cross-over, single-dose study in healthy volunteers.hereditary tyrosinemia type 110027424NL-OMON39261PRA International EDS12
已完成
1 期
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the SuspensionHealthy VolunteersNCT01682538Swedish Orphan Biovitrum12
已完成
1 期
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.HealthyNCT01857362Swedish Orphan Biovitrum12
尚未招募
不适用
Study of absorption and elimination rate of Pirfenidone 200-mg Tablets in comparison with Pirfenidone brand Tablets (Pirfenex®).Bioequivalence study.IRCT20200407046981N30Modava pharmaceutical company24
招募中
不适用
In-vivo Bioequivalence Test of Pirfenidone tablet 200 mg Arang Pharma with brand drug (PIRFENEX® 200mg, Cipla, India)IRCT20200105046010N61Arang Pharm Co.24