HealthyPhase 1NCT02209649
Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects
A Phase 1 study testing Lacidipine and Telmisartan fixed dose combination (FDC) tablet, Lacidipine and Telmisartan in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lacidipine and Telmisartan fixed dose combination (FDC) tablet, Lacidipine and Telmisartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 1999to Dec 1999
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female Caucasian subjects as determined by results of screening
- Age ≥ 18 and ≤ 50 years
- Broca ≥ - 20 % and ≤ + 20 %
- Written informed consent in accordance with Good Clinical Practice and local legislation given
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 19Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) (≤ 1 month prior to administration or during the trial, except for oral contraceptives)
- Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
- Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
- Excessive physical activities (≤ 10 days prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- Females only:
- no reliable contraception (e.g. oral contraceptives, 3-month injection, intrauterine device, sterilisation)
- pregnancy of breast feeding period
About this study
Official title: Bioavailability of Lacidipine 4 mg and Telmisartan 40 mg Administered Orally as Two Experimental Fixed Dose Combination Tablets Relative to Separate Tablets. An Open Randomised Three-way Cross-over Steady State Trial in 6 Female and 6 Male Healthy Subjects
Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.
- Conditions
- Healthy
- Being tested
- Lacidipine and Telmisartan fixed dose combination (FDC) tablet, Lacidipine, Telmisartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacidipine and Telmisartan fixed dose combination (FDC) tabletDrug
LacidipineDrug
TelmisartanDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan and Lacidipine FDC, formulation A | Experimental | Not described Receives: Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet |
| Telmisartan and Lacidipine FDC, formulation B | Experimental | Not described Receives: Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet |
| Lacidipine and Telmisartan, mono | Active comparator | Not described Receives: Drug: Lacidipine; Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve at steady state (AUCss)
Measured: up to 72 hours after drug administration at day 7
Maximum concentration (Cmax,ss)
Measured: up to 72 hours after drug administration at day 7
Time to maximum concentration (tmax)
Measured: up to 72 hours after drug administration at day 7
Total apparent clearance (CLtot/f)
Measured: up to 72 hours after drug administration at day 7
Apparent volume of distribution (Vz/f)
Measured: up to 72 hours after drug administration at day 7
Mean residence time (MRTss)
Measured: up to 72 hours after drug administration at day 7
Terminal half-life (t1/2)
Measured: up to 72 hours after drug administration at day 7
Number of patients with adverse events
Measured: up to 66 days
Number of patients with abnormal findings in physical examination
Measured: up to 66 days
Number of patients with clinically relevant changes in electrocardiogram
Measured: up to 66 days
Number of patients with clinically relevant changes in vital signs
Measured: up to 66 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to 66 days
Assessment of tolerability on a verbal rating scale
Measured: between day 3 and 5 after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startOct 1999
- Primary completionDec 1999
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
- 12 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
- NCT02209649
- Sponsor's protocol ID
- 1173.6
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Lacidipine 4 mg and Telmisartan 40 mg Administered Orally as Two Experimental Fixed Dose Combination Tablets Relative to Separate Tablets. An Open Randomised Three-way Cross-over Steady State Trial in 6 Female and 6 Male Healthy Subjects
- ClinicalTrials.gov ID
- NCT02209649
- Acronym / sponsor ID
- 1173.6
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1999
- Primary completion
- Dec 1999 (actual)
- First posted
- 6 Aug 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.
Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telmisartan and Lacidipine FDC, formulation A | Experimental | Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet |
| Telmisartan and Lacidipine FDC, formulation B | Experimental | Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet |
| Lacidipine and Telmisartan, mono | Active comparator | Drug: Lacidipine, Drug: Telmisartan |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female Caucasian subjects as determined by results of screening
- Age ≥ 18 and ≤ 50 years
- Broca ≥ - 20 % and ≤ + 20 %
- Written informed consent in accordance with Good Clinical Practice and local legislation given
Key exclusion criteria (19 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
- History of orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Lacidipine and Telmisartan fixed dose combination (FDC) tablet | Drug | Telmisartan and Lacidipine FDC, formulation A, Telmisartan and Lacidipine FDC, formulation B |
| Lacidipine | Drug | Lacidipine and Telmisartan, mono |
| Telmisartan | Drug | Lacidipine and Telmisartan, mono |
Primary outcome
Area under the curve at steady state (AUCss)
Time frame: up to 72 hours after drug administration at day 7
Maximum concentration (Cmax,ss)
Time frame: up to 72 hours after drug administration at day 7
Time to maximum concentration (tmax)
Time frame: up to 72 hours after drug administration at day 7
Total apparent clearance (CLtot/f)
Time frame: up to 72 hours after drug administration at day 7
Apparent volume of distribution (Vz/f)
Time frame: up to 72 hours after drug administration at day 7
Mean residence time (MRTss)
Time frame: up to 72 hours after drug administration at day 7
Terminal half-life (t1/2)
Time frame: up to 72 hours after drug administration at day 7
Number of patients with adverse events
Time frame: up to 66 days
Number of patients with abnormal findings in physical examination
Time frame: up to 66 days
Number of patients with clinically relevant changes in electrocardiogram
Time frame: up to 66 days
Number of patients with clinically relevant changes in vital signs
Time frame: up to 66 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 66 days
Assessment of tolerability on a verbal rating scale
Time frame: between day 3 and 5 after last study drug administration
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 6 Aug 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 Lacidipine and Telmisartan fixed dose combination (FDC) tablet, Lacidipine and Telmisartan 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 19 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 6 Aug 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 curve at steady state (AUCss) (time frame: up to 72 hours after drug administration at day 7). The study lists 13 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 6 Aug 2014.