Bioavailability, Therapeutical Indication Not StudiedPhase 1NCT00884442
Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions
A Phase 1 study testing Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL) and Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) in people with Bioavailability, Therapeutical Indication Not Studied, run by SocraTec R&D GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability, Therapeutical Indication Not Studied
- What is being tested?
- Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL) and Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
- subjects who are on a diet which could affect the pharmacokinetics of the drug
- regular intake of caffeine containing food or beverages of ≥ 500 mg (calculated as caffeine) per day
- heavy smokers (≥ 10 cigarettes per day or equivalents of other nicotine containing products)
- blood donation or other blood loss of more than 400 ml within the last two months prior to the start of the study
- participation in a clinical trial during the last two months prior to individual enrolment of the subject
- regular treatment with any systemically available medication (except hormonal replacement therapy e.g. L-thyroxine)
- subjects, who report a frequent occurrence of migraine attacks Administrative reasons
- subjects suspected or known not to follow instructions
- subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL), Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)
- Keywords
- Healthy, Bioavailability, Nifedipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)Drug
Also called Nifedipine 60 mg, GITS
60 mg nifedipine
Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)Drug
60 mg nifedipine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | One tablet of Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL, fasted state Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability, Therapeutical Indication Not StudiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SocraTec R&D GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- SocraMetrics GmbH
- Investigators
- Frank Donath, MD, Principal investigator, SocraTec R&D GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884442
- Sponsor's protocol ID
- 1215ni09ct
- Status last verified
- Oct 2009
- First submitted
- 17 Apr 2009
- Last updated
- 21 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00884442
- Acronym / sponsor ID
- 1215ni09ct
- Keywords
- Healthy, Bioavailability, Nifedipine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SocraTec R&D GmbHUniversity, hospital or other
- Collaborators
- SocraMetrics GmbH
- Study start
- Apr 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)One tablet of Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL, fasted state |
| 2 | Active comparator | Drug: Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)One tablet of Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL, fed state |
| 3 | Active comparator | Drug: Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)One tablet of Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS, fasted state |
| 4 | Active comparator | Drug: Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)One tablet of Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS, fed state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)Also: Nifedipine 60 mg, GITS60 mg nifedipine | Drug | 1, 2 |
| Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)60 mg nifedipine | Drug | 3, 4 |
Primary outcome
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
1 secondary outcome
Descriptive characterisation of safety and tolerability of the investigational products in the study population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Donath, MD principal investigator
SocraTec R&D GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL) and Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) in people with Bioavailability, Therapeutical Indication Not Studied, run by SocraTec R&D GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2009.