NCT00884442

Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions

Randomized, Non-blind, 4-fold Crossover Study on Safety, Tolerability and Pharmacokinetics of Nifedipine After Single Oral Doses of Adalat® LA 60 mg or of a Marketed Generic Version of Nifedipine Retard 60 mg After an Overnight Fasting or Immediately After a High-fat American Breakfast in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: SocraTec R&D GmbH · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study will be performed to investigate and to compare the in-vivo performance of the two investigational products Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic parameters after oral single dose administrations in the fasted and fed state.

Detailed description

In the past, several attempts have been made to develop nifedipine formulations with pharmacokinetic characteristics similar to the unique characteristics of nifedipine GITS. A new extended release nifedipine tablet based on an osmotically active system for once a day administration has been registered under the trade name Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) in Canada. According to the product monograph of Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL), this tablet consists of a semipermeable membrane surrounding an osmotically active drug core. After contact with water from the GI tract osmotic pressure in the core increases, releasing the active drug at a controlled rate through an orifice in the tablet membrane. The functional principle of this nifedipine tablet seems to be quite similar to the one of the GITS system. However, especially in case of modified release formulations, various factors can affect the absorption and the systemic availability of the drug. Two important factors are i) the drug release rate from the dosage form and ii) the gastrointestinal transit rate, which in turn has an influence on the site of absorption. Especially food intake and the caloric content of a meal can affect drug transit time, luminal dissolution and drug permeability. Thus, the prandial state may have a significant impact on the in vivo behaviour of such formulations as a whole and particularly on the drug bioavailability. For GITS formulations, such as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS, earlier studies have demonstrated that no significant influence of concomitant food-intake occurs.

Conditions

• Bioavailability, Therapeutical Indication Not Studied

Interventions

Type	Name	Description
DRUG	Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)	60 mg nifedipine
DRUG	Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)	60 mg nifedipine

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-04-20
• Last updated: 2009-10-21

Locations

1 site across 1 country: Germany