BioequivalencePhase 1NCT03705533
Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State
A Phase 1 study testing Telmisartan and Micardis in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Canada.
Trial summary
This single center, randomized, single dose, full replicate, crossover comparative laboratory-blinded study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after oral administration under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Telmisartan and Micardis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2018to 19 Dec 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy male or female adult volunteer
- A female volunteer meeting one of the following criteria:
- (1) Physiological postmenopausal status, defined as the following:
- absence of menses for at least one year prior to the first study drug administration (not due to amenorrhea secondary to lactation); and
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- Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening; OR
- (2) Surgical postmenopausal status, defined as the following:
- bilateral oophorectomy; and
- absence of menses for at least 90 days prior to the first study drug administration; and
- FSH levels ≥ 40 mIU/mL at screening; OR
- (3) Hysterectomy with FSH levels ≥ 40 mIU/mL at screening
- If the postmenopausal volunteer has an FSH of < 40 mIU/mL, but meets the above criteria in either (1), (2) or (3) and all the other inclusion criteria, the volunteer may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, inclusion of the volunteer will be based on medical judgment.
- Volunteer aged at least 18 years but not older than 55 years
- Volunteer with a body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
- Light-, non- or ex-smoker. A light smoker is defined as someone using 10.0 nicotine units or less per day for at least 90 days prior to the first study drug administration. An ex smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
Who cannot join
- Females who are pregnant according to the pregnancy test at screening
- Seated blood pressure below 105/60 mmHg at the screening visit or prior to the first study drug administration
- History of significant hypersensitivity to telmisartan or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
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- Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment
- History of rare hereditary problems of fructose, galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the 28 days prior to the first study drug administration
- Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the volunteer as healthy
- Any history of tuberculosis
- Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
- Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests
- Volunteers who have already been included in a previous group for this clinical study
- Volunteers who took telmisartan in the 28 days prior to the first study drug administration
- Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration
- Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration
Trial locations and contacts
1 site in 1 country.
Canada1 site
Algorithme Pharma, An Altasciences Company
Mount Royal, Quebec, H3P 3P1
About this study
Official title: Single Dose, Full Replicate, Crossover Comparative Bioavailability Study of Telmisartan 80 mg Tablets in Healthy Male and Female Volunteers / Fasting State
This single center, randomized, single dose, full replicate, crossover comparative laboratory-blinded study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after oral administration under fasting conditions.
Read the detailed description
The study is characterized by single center, randomized, single dose, laboratory-blinded, 4-period, 2-sequence, full replicate crossover design.The objective is to determine the bioequivalence of two different formulations of telmisartan after a single oral dose administration under fasting conditions. The test product is Telmisartan 80 mg tablets manufactured by Pharmtechnology LLC, Belarus. The reference product is Micardis 80 mg tablets manufactured by Boehringer Ingelheim Ellas AE, Greece. The primary study endpoints are the pharmacokinetic parameters Cmax and AUC0-T of telmisartan.
Eligible 26 healthy adult subjects will be randomized to the one of two predetermined sequences: ABAB or BABA where A = the test product, B = the reference product. Clinical part of the study will include 4 periods; in each of them a single 80 mg dose of telmisartan will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast. Wash-out period between treatment administrations will last at least 14 calendar days.
Subjects will be confined to the clinical site from at least 10 hours prior to each drug administration until 24 hours following each drug administration. Subjects will return to the clinical site for the remaining blood samples.
In each study period, 21 blood samples will be collected for pharmacokinetic assessments. The first blood sample will be collected prior to drug administration while the others will be collected up to 72 hours after drug administration (0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 postdose) .
Total study duration: up to 74 days (including screening).
Telmisartan plasma concentrations will be measured by a validated bioanalytical method.
Statistical analysis of pharmacokinetic parameters will be based on an ANOVA model. Two-sided 90% confidence interval of the ratio of geometric LSmeans will be obtained from the ln-transformed pharmacokinetic parameters.
Statistical inference of telmisartan will be based on a bioequivalence approach using the following standards:
- average bioequivalence (the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the test and the reference product for the ln-transformed parameters Cmax and AUC0-T should all be within the 80.00 to 125.00% bioequivalence range);
- scaled-average-bioequivalence (in the event that the Cmax reference-to-reference within-subject CV is greater than 30%, that its test-to-reference geometric LSmeans ratio is within the bioequivalence range of 80.00 125.00% and the average bioequivalence criteria are not met, a scaling approach to the bioequivalence assessment will be used).
- Conditions
- Bioequivalence
- Being tested
- Telmisartan, Micardis
- Keywords
- telmisartan, bioequivalence, Micardis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Also called the test product
Telmisartan is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 80 mg of telmisartan.
MicardisDrug
Also called the reference product
Micardis is manufactured by Boehringer Ingelheim Ellas AE, Greece. Each tablet contains 80 mg of telmisartan.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABAB | Other | Subjects assigned to sequence ABAB will receive a single 80 mg dose of the test product Telmisartan (1 x 80 mg tablet) marked as A in the sequence in Periods 1 and 3 and a single 80 mg dose of the reference product Micardis (1 x 80 mg tablet) marked as B in the sequence in periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Telmisartan; Drug: Micardis |
| Sequence BABA | Other | Subjects assigned to sequence BABA will receive a single 80 mg dose of the reference product Micardis (1 x 80 mg tablet) marked as B in the sequence in periods 1 and 3 and a single 80 mg dose of the test product Telmisartan (1 x 80 mg tablet) marked as A in the sequence in Periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Telmisartan; Drug: Micardis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of telmisartan for the test and the reference products
Maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
AUC0-T of telmisartan for the test and the reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Secondary outcomes (7)
Tmax of telmisartan for the test and the reference products
Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
TLQC of telmisartan for the test and the reference products
Time of last observed quantifiable concentration
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
AUC0-∞ of telmisartan for the test and the reference products
Area under the concentration time curve extrapolated to infinity, calculated as AUC0-T + ĈLQC/λZ, where ĈLQC is the predicted concentration at time TLQC
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Residual area of telmisartan for the test and the reference products
Extrapolated area (i.e. percentage of AUC0-∞ due to extrapolation from TLQC to infinity)
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
TLIN of telmisartan for the test and the reference products
Time point where the log-linear elimination phase begins
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
λZ of telmisartan for the test and the reference products
Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Thalf of telmisartan for the test and the reference products
Terminal elimination half-life, calculated as ln(2)/λZ
Measured: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start7 Sep 2018
- Primary completion16 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In compliance with full replicate design there are two sequences in the study: ABAB and BABA where A = the test product, B = the reference product (see detailed description of items below).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma, An Altasciences Company
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, MD, Principal investigator, Altasciences Company Inc. (doing business as Algorithme Pharma)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705533
- Sponsor's protocol ID
- PTL-P3-923
- Status last verified
- Dec 2018
- First submitted
- 8 Oct 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Full Replicate, Crossover Comparative Bioavailability Study of Telmisartan 80 mg Tablets in Healthy Male and Female Volunteers / Fasting State
- ClinicalTrials.gov ID
- NCT03705533
- Acronym / sponsor ID
- PTL-P3-923
- Conditions
- Bioequivalence
- Keywords
- telmisartan, bioequivalence, Micardis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma, An Altasciences Company
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 16 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 15 Oct 2018 (actual)
- 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.
This single center, randomized, single dose, full replicate, crossover comparative laboratory-blinded study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after oral administration under fasting conditions.
Detailed description
The study is characterized by single center, randomized, single dose, laboratory-blinded, 4-period, 2-sequence, full replicate crossover design.The objective is to determine the bioequivalence of two different formulations of telmisartan after a single oral dose administration under fasting conditions. The test product is Telmisartan 80 mg tablets manufactured by Pharmtechnology LLC, Belarus. The reference product is Micardis 80 mg tablets manufactured by Boehringer Ingelheim Ellas AE, Greece. The primary study endpoints are the pharmacokinetic parameters Cmax and AUC0-T of telmisartan.
Eligible 26 healthy adult subjects will be randomized to the one of two predetermined sequences: ABAB or BABA where A = the test product, B = the reference product. Clinical part of the study will include 4 periods; in each of them a single 80 mg dose of telmisartan will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast. Wash-out period between treatment administrations will last at least 14 calendar days.
Subjects will be confined to the clinical site from at least 10 hours prior to each drug administration until 24 hours following each drug administration. Subjects will return to the clinical site for the remaining blood samples.
In each study period, 21 blood samples will be collected for pharmacokinetic assessments. The first blood sample will be collected prior to drug administration while the others will be collected up to 72 hours after drug administration (0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 postdose) .
Total study duration: up to 74 days (including screening).
Telmisartan plasma concentrations will be measured by a validated bioanalytical method.
Statistical analysis of pharmacokinetic parameters will be based on an ANOVA model. Two-sided 90% confidence interval of the ratio of geometric LSmeans will be obtained from the ln-transformed pharmacokinetic parameters.
Statistical inference of telmisartan will be based on a bioequivalence approach using the following standards:
- average bioequivalence (the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the test and the reference product for the ln-transformed parameters Cmax and AUC0-T should all be within the 80.00 to 125.00% bioequivalence range);
- scaled-average-bioequivalence (in the event that the Cmax reference-to-reference within-subject CV is greater than 30%, that its test-to-reference geometric LSmeans ratio is within the bioequivalence range of 80.00 125.00% and the average bioequivalence criteria are not met, a scaling approach to the bioequivalence assessment will be used).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In compliance with full replicate design there are two sequences in the study: ABAB and BABA where A = the test product, B = the reference product (see detailed description of items below).
| Arm | Type | Receives |
|---|---|---|
| Sequence ABAB | Other | Drug: Telmisartan, Drug: MicardisSubjects assigned to sequence ABAB will receive a single 80 mg dose of the test product Telmisartan (1 x 80 mg tablet) marked as A in the sequence in Periods 1 and 3 and a single 80 mg dose of the reference product Micardis (1 x 80 mg tablet) marked as B in the sequence in periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence BABA | Other | Drug: Telmisartan, Drug: MicardisSubjects assigned to sequence BABA will receive a single 80 mg dose of the reference product Micardis (1 x 80 mg tablet) marked as B in the sequence in periods 1 and 3 and a single 80 mg dose of the test product Telmisartan (1 x 80 mg tablet) marked as A in the sequence in Periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy male or female adult volunteer
- A female volunteer meeting one of the following criteria:
- If the postmenopausal volunteer has an FSH of < 40 mIU/mL, but meets the above criteria in either (1), (2) or (3) and all the other inclusion criteria, the volunteer may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, inclusion of the volunteer will be based on medical judgment.
Key exclusion criteria (19 listed)
- Females who are pregnant according to the pregnancy test at screening
- Seated blood pressure below 105/60 mmHg at the screening visit or prior to the first study drug administration
- History of significant hypersensitivity to telmisartan or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
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 |
|---|---|---|
| TelmisartanAlso: the test productTelmisartan is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 80 mg of telmisartan. | Drug | Sequence ABAB, Sequence BABA |
| MicardisAlso: the reference productMicardis is manufactured by Boehringer Ingelheim Ellas AE, Greece. Each tablet contains 80 mg of telmisartan. | Drug | Sequence ABAB, Sequence BABA |
Primary outcome
Cmax of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-T of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration
7 secondary outcomes
Tmax of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
TLQC of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
AUC0-∞ of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Residual area of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
TLIN of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
λZ of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
Thalf of telmisartan for the test and the reference products
Time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after 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 27 Dec 2018.
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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.
Eric Sicard, MD principal investigator
Altasciences Company Inc. (doing business as Algorithme Pharma)
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 Telmisartan and Micardis in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Canada.
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 18 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 27 Dec 2018. 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 Canada. 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?
Cmax of telmisartan for the test and the reference products (time frame: Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 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 27 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.