Study title: A Randomized Open-Label Study to Compare the Relative Bioavailability of 170 mg of Modafinil Film-Coated Tablets to 200 mg of PROVIGIL® and to Assess the Pharmacokinetic and Safety Profile of Multiple Doses of the Modafinil Film-Coated Tablets Administered at Doses of 340 and 425 mg to Children and Adolescents With Attention-Deficit/Hyperactivity Disorder.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases | |||||
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MAH holders: | |||||
Assessment: | |||||
Active substance: MODAFINIL | |||||
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Document link: EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls | |||||
Document date: 2011-09-19 | |||||
Study number: C1538d/113/BA/US | |||||
EudraCT number: | |||||
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Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
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