Bioavailability studies

View comparative bioavailability studies under fed and fasting conditions.

Single Oral Dose (1 x 18 mg) Comparative Bioavailability

Single oral dose (1 x 18 mg) comparative bioavailability study under fed conditions

Mean methylphenidate concentration-time profiles after administration of the test formulation (treatment A) and the reference product (treatment B)^1,2,†

Single oral dose (1 x 18 mg) comparative bioavailability study under fasting conditions

Mean methylphenidate concentration-time profiles after administration of the test formulation (treatment A) and the reference product (treatment B)^1,3,‡

^†A single-dose, two-period, two-treatment, two-way crossover bioequivalence study of methylphenidate hydrochloride 18 mg extended-release tablets (Teva Canada Limited) and Concerta^® (methylphenidate hydrochloride) 18 mg extended-release tablets by Janssen Inc., Canada was conducted in healthy adult subjects under fed conditions.

^‡A single-dose, two-period, two-treatment, two-way crossover bioequivalence study of methylphenidate hydrochloride 18 mg extended-release tablets (Teva Canada Limited) and Concerta^® (methylphenidate hydrochloride) 18 mg extended-release tablets by Janssen Inc., Canada was conducted in healthy adult subjects under fasting conditions.

Single oral dose (1 x 54 mg) comparative bioavailability study

Single oral dose (1 x 54 mg) comparative bioavailability study under fed conditions

Mean methylphenidate concentration-time profiles after administration of the test formulation (treatment A) and the reference product (treatment B)^1,2,§

Single oral dose (1 x 54 mg) comparative bioavailability study under fasting conditions

Mean methylphenidate concentration-time profiles after administration of the test formulation (treatment A) and the reference product (treatment B)^1,3,#

^§A single-dose, two-period, two-treatment, two-way crossover bioequivalence study of methylphenidate hydrochloride 18 mg extended-release tablets (Teva Canada Limited) and Concerta^® (methylphenidate hydrochloride) 54 mg extended-release tablets by Janssen Inc., Canada was conducted in healthy adult subjects under fed conditions.

^#A single-dose, two-period, two-treatment, two-way crossover bioequivalence study of methylphenidate hydrochloride 18 mg extended-release tablets (Teva Canada Limited) and Concerta^® (methylphenidate hydrochloride) 54 mg extended-release tablets by Janssen Inc., Canada was conducted in healthy adult subjects under fasting conditions.

References:

Teva Canada Limited. ACT Methylphenidate ER Product Monograph. February 14, 2024.
Data on File Study #3006968.
Data on File Study #3006969.
Data on file Study #11109864.
Data on file Study #11109863.