Bioequivalence study with two different oral formulations of methocarbamol in healthy subjects. A mono-centre, comparative, randomized, open-label, single-dose, 2-way crossover study.

Objective: The objective of this study was to compare the pharmacokinetic profile of a new oral methocarbamol (CAS 532-03-6) formulation (DoloVisano Methocarbamol 750 mg Tabletten) to that of a registered reference product and to demonstrate the bioequivalence of the formulations with respect to rate and extent of methocarbamol exposure.

Method: This bioequivalence trial was based on an open-label, single-dose, randomized, two-treatment, two-period crossover design. In each period 32 male or female healthy white volunteers received 2 tablets (2 x 750 mg methocarbamol) of either the test (a) or the reference (b) product after an overnight fasting of at least 12 h.

Proof of systemic safety of a lidocaine ointment in the treatment of patients with anorectal pain.

Objective: The aim of the study was to demonstrate that repeated anorectal administration of a 5% lidocaine ointment (CAS 137-58-6; LidoPosterine Salbe, Posterisan akut Rektalsalbe) in the treatment of patients with acute anorectal pain does not result in systemically efficacious plasma concentrations of lidocaine.

Patients And Methods: In an open single-center study 24 male or female patients with anorectal pain due to hemorrhoids, anal fissures, fistulas or proctitis administered lidocaine ointment as a single anorectal dose (2.5 g ointment corresponding to 125 mg lidocaine) followed by repeated administration (2.

[Pharmacokinetic comparison of progesterone capsules with a progesterone gel after vaginal administration].

The transvaginal bioavailability of 200 mg progesterone (CAS 57-83-0) from a vaginal capsule (Utrogest 200) compared to a vaginal gel containing 90 mg progesterone per dose was evaluated in 24 healthy young women using a randomised two-period cross-over design. Both treatments were supposed to release comparable amounts of progesterone. Blood samples were taken over a period of 96 h following single administration.