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

NCT00884442 | Completed Phase 1

• 1 other identifier: 1215ni09ct
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioavailability, Therapeutical Indication Not Studied

Keywords

Healthy; Bioavailability; Nifedipine

Outcome Measures

Primary Outcomes (1)

• PK parameters after s.d. of 60 mg Nifedipine(Bayer Healthcare AG manufactured asAdalat XL,Adalat LA,Adalat Crono,Adalat OROS)and Gen-nifedipine extended release,(previously named as Gen-Nifedipine XL),administered under fasting/fed condition

Secondary Outcomes (1)

• Descriptive characterisation of safety and tolerability of the investigational products in the study population

Study Arms (4)

1

ACTIVE COMPARATOR

One tablet of Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL, fasted state

Drug: Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)

2

ACTIVE COMPARATOR

One tablet of Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL, fed state

Drug: Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)

3

ACTIVE COMPARATOR

One tablet of Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS, fasted state

Drug: Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)

4

ACTIVE COMPARATOR

One tablet of Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS, fed state

Drug: Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)

Interventions

Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL) DRUG

60 mg nifedipine

Also known as: Nifedipine 60 mg, GITS

1; 2

Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) DRUG

60 mg nifedipine

3; 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• sex: male
• ethnic origin: Caucasian
• age: 18 - 55 years, inclusive
• body-mass index (BMI): ³ 22 kg/m² and £ 27 kg/m²
• good state of health (no clinically significant deviations from normal clinical results and laboratory findings)
• the subject must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subject's participating in the study

You may not qualify if:

• existing cardiac or haematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
• existing hepatic and/or renal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
• existing gastrointestinal diseases and/or pathological findings, including severe gastrointestinal or esophageal constriction or narrowing, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
• history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
• relevant pathological changes in the ECG (12 standard leads) such as a second- or third-degree AV block, complete bundle branch block, prolongation of the QRS complex over 120 msec or the QTc-interval above 450 msec
• known allergic or intolerance reactions to the active ingredient used or to constituents of the pharmaceutical preparations (e.g. lactose intolerance)
• subjects with severe allergies or multiple drug allergies
• systolic blood pressure below 110 mmHg or above 155 mmHg
• diastolic blood pressure below 60 mmHg or above 95 mmHg
• resting heart rate in the awake subject below 45 bpm or above 90 bpm
• laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
• positive anti-HIV-test, HBs-AG-test or anti-HCV-test Lack of suitability for the trial
• acute or chronic diseases which could affect absorption or metabolism
• history of or current drug or alcohol dependence
• regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol per day

Sponsors & Collaborators

• SocraTec R&D GmbH: lead
• SocraMetrics GmbH: collaborator

Study Sites (1)

SocraTec R&D Probandenstation

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Frank Donath, MD

  SocraTec R&D GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 21, 2009

Record last verified: 2009-10

Locations

DE (1)