HealthyPhase 1NCT02195804
Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male Volunteers
A Phase 1 study testing Ranitidine hydrochloride ODT, Ranitidine hydrochloride ODT RM and Ranitidine hydrochloride in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to establish the relative bioavailability (BA) of two different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation following oral single dose administration in fasting… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ranitidine hydrochloride ODT, Ranitidine hydrochloride ODT RM and Ranitidine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jun 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects based on: complete medical history, including a physical examination, vital signs (pulse rate (PR), systolic \& diastolic blood pressure (BP) and body temperature), 12-lead electrocardiogram (ECG) and clinical laboratory tests
- Age ≥ 18 and Age ≤ 60 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index) and body weight of ≥ 55 kg
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- Any clinically relevant abnormality found on the screening physical examination (including BP, PR) or ECG or in the opinion of the investigator the patient is not suitable for the study
- Any evidence of an acute or chronic gastrointestinal conditions or relevant concomitant medical disease
- History of acute porphyria
- History of peptic ulcer disease
- Heartburn requiring treatment (OTC or prescription medicine) within the last 30 days
- History of surgery of the gastrointestinal tract surgery (except appendectomy and cholecystectomy)
Show all 18Show fewer
- History of relevant allergy / hypersensitivity (including allergy to H2 inhibitor) to the drug class, ranitidine hydrochloride or its excipients)
- Intake of prescription or over-the-counter (OTC) drugs with a long half-life (>24 hours) within at least 2 weeks or less than 10 half-lives of the respective drug prior to administration or during the trial
- Participation in another trial with an investigational drug within 30 days prior to administration or during the trial
- Inability to refrain from alcohol use 48 hours prior to drug administration until the end of the study visit for each treatment period
- History of alcohol (more than 60 g/day) or drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance as determined by the investigator
- Inability to comply with dietary regimen of trial site
- Subjects who test positive upon drug screening
- Subjects who consume caffeine or xanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) 48 hours prior to study drug administration
- Subjects who consume citrus fruits and juices, (in particular grapefruits and Seville oranges, sour or bitter oranges), or products containing St. John's wort (Hypericum perforatum) are not allowed 7 days prior to dose administration
- Excessive physical activity or exercise (such as organized sports) during the trial period
About this study
Official title: A Phase I Open-label, Randomised, Single Dose, Three-way Crossover Relative Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) Formulations Following Oral Administration in Fasting, Healthy Male Volunteers
The objective of this study is to establish the relative bioavailability (BA) of two different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation following oral single dose administration in fasting healthy male volunteers
- Conditions
- Healthy
- Being tested
- Ranitidine hydrochloride ODT, Ranitidine hydrochloride ODT RM, Ranitidine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranitidine hydrochloride ODTDrug
Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)
Ranitidine hydrochloride ODT RMDrug
Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)
Ranitidine hydrochlorideDrug
Also called Maximum Strength ZANTAC 150®
| Study group | Role | What they receive |
|---|---|---|
| Ranitidine HCL ODT Vanilla-Mint | Experimental | Not described Receives: Drug: Ranitidine hydrochloride ODT |
| Ranitidine HCL ODT RM Vanilla-Mint | Experimental | Not described Receives: Drug: Ranitidine hydrochloride ODT RM |
| Ranitidine HCL | Active comparator | Maximum Strength ZANTAC 150® Receives: Drug: Ranitidine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 16 hours after drug administration
Maximum measured concentration of ranitidine in plasma (Cmax)
Measured: up to 16 hours after drug administration
Secondary outcomes (9)
Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Measured: up to 16 hours after drug administration
Time from dosing to the maximum concentration of ranitidine in plasma (tmax)
Measured: up to 16 hours after drug administration
Terminal rate constant in plasma (λz)
Measured: up to 16 hours after drug administration
Terminal half-life of ranitidine in plasma (t1/2)
Measured: up to 16 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
Measured: up to 16 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Measured: up to 16 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: up to 16 hours after drug administration
Number of patients with adverse events
Measured: up to 38 days
Global assessment of tolerability by investigator on a 4-point scale
Measured: 24 hours after drug dosing at the end of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startMay 2009
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195804
- Sponsor's protocol ID
- 1144.3
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Randomised, Single Dose, Three-way Crossover Relative Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) Formulations Following Oral Administration in Fasting, Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02195804
- Acronym / sponsor ID
- 1144.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- First posted
- 21 Jul 2014 (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 objective of this study is to establish the relative bioavailability (BA) of two different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation following oral single dose administration in fasting healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ranitidine HCL ODT Vanilla-Mint | Experimental | Drug: Ranitidine hydrochloride ODT |
| Ranitidine HCL ODT RM Vanilla-Mint | Experimental | Drug: Ranitidine hydrochloride ODT RM |
| Ranitidine HCL | Active comparator | Drug: Ranitidine hydrochlorideMaximum Strength ZANTAC 150® |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects based on: complete medical history, including a physical examination, vital signs (pulse rate (PR), systolic \& diastolic blood pressure (BP) and body temperature), 12-lead electrocardiogram (ECG) and clinical laboratory tests
- Age ≥ 18 and Age ≤ 60 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index) and body weight of ≥ 55 kg
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (18 listed)
- Any clinically relevant abnormality found on the screening physical examination (including BP, PR) or ECG or in the opinion of the investigator the patient is not suitable for the study
- Any evidence of an acute or chronic gastrointestinal conditions or relevant concomitant medical disease
- History of acute porphyria
- History of peptic ulcer disease
- Heartburn requiring treatment (OTC or prescription medicine) within the last 30 days
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 |
|---|---|---|
| Ranitidine hydrochloride ODTRanitidine hydrochloride ODT#1 150 mg (Vanilla-Mint) | Drug | Ranitidine HCL ODT Vanilla-Mint |
| Ranitidine hydrochloride ODT RMRanitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2) | Drug | Ranitidine HCL ODT RM Vanilla-Mint |
| Ranitidine hydrochlorideAlso: Maximum Strength ZANTAC 150® | Drug | Ranitidine HCL |
Primary outcome
Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 16 hours after drug administration
Maximum measured concentration of ranitidine in plasma (Cmax)
Time frame: up to 16 hours after drug administration
9 secondary outcomes
Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Time frame: up to 16 hours after drug administration
Time from dosing to the maximum concentration of ranitidine in plasma (tmax)
Time frame: up to 16 hours after drug administration
Terminal rate constant in plasma (λz)
Time frame: up to 16 hours after drug administration
Terminal half-life of ranitidine in plasma (t1/2)
Time frame: up to 16 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)
Time frame: up to 16 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: up to 16 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 16 hours after drug administration
Number of patients with adverse events
Time frame: up to 38 days
Global assessment of tolerability by investigator on a 4-point scale
Time frame: 24 hours after drug dosing at the end of each treatment period
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 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ranitidine hydrochloride ODT, Ranitidine hydrochloride ODT RM and Ranitidine hydrochloride in people with Healthy, run by Boehringer Ingelheim.
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 4 inclusion and 18 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: up to 16 hours after drug administration). The study lists 2 primary outcomes in all. 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 Jul 2014.