Bioequivalence Clinical Trial
Official title:
Single Dose, Full Replicate, Crossover Comparative Bioavailability Study of Telmisartan 80 mg Tablets in Healthy Male and Female Volunteers / Fasting State
Verified date | December 2018 |
Source | Pharmtechnology LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 19, 2018 |
Est. primary completion date | December 16, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy male or female adult volunteer 4. 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 - 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. 5. Volunteer aged at least 18 years but not older than 55 years 6. Volunteer with a body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively 7. 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 8. 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 9. 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 Exclusion Criteria: 1. Females who are pregnant according to the pregnancy test at screening 2. Seated blood pressure below 105/60 mmHg at the screening visit or prior to the first study drug administration 3. 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 4. 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 5. History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy 6. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease 7. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment 8. History of rare hereditary problems of fructose, galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption 9. 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) 10. Any clinically significant illness in the 28 days prior to the first study drug administration 11. 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 12. Any history of tuberculosis 13. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration 14. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests 15. Volunteers who have already been included in a previous group for this clinical study 16. Volunteers who took telmisartan in the 28 days prior to the first study drug administration 17. Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration 18. Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration 19. 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Algorithme Pharma, An Altasciences Company | Mount-Royal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Pharmtechnology LLC | Algorithme Pharma, An Altasciences Company |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of treatment-related adverse events (AE) for the test and the reference products | The safety population will include all subjects who received at least one dose of one of the investigational products. All AEs will be graded as mild, moderate, or severe according to the pre-specified definitions. The qualified investigator will determine the relationship of any AE to the study drug using pre-specified criteria (reasonable possibility or no reasonable possibility). Classification of AEs will be performed by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 20.1 or higher. | From the first dosing until 3 days after the collection of the last blood sample of the study | |
Primary | Cmax of telmisartan for the test and the reference products | Maximum concentration in plasma among observed concentrations at pre-specified time points | 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 | |
Primary | 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 | 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 | 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 | 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 | TLQC of telmisartan for the test and the reference products | Time of last observed quantifiable concentration | 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 | AUC0-8 of telmisartan for the test and the reference products | Area under the concentration time curve extrapolated to infinity, calculated as AUC0-T + CLQC/?Z, where CLQC is the predicted concentration at time TLQC | 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 | Residual area of telmisartan for the test and the reference products | Extrapolated area (i.e. percentage of AUC0-8 due to extrapolation from TLQC to infinity) | 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 | TLIN of telmisartan for the test and the reference products | Time point where the log-linear elimination phase begins | 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 | ?Z 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 | 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 | Thalf of telmisartan for the test and the reference products | Terminal elimination half-life, calculated as ln(2)/?Z | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04938856 -
Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
|
Phase 1 | |
Completed |
NCT03646331 -
Bioequivalence of Imeglimin Tablet Formulations
|
Phase 1 | |
Completed |
NCT04564456 -
A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05197517 -
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
|
Phase 1 | |
Completed |
NCT03702894 -
Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
|
Phase 1 | |
Withdrawn |
NCT02894515 -
Bioequivalence Study of Idalopirdine in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03018015 -
Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
|
Phase 1 | |
Completed |
NCT02206295 -
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
|
Phase 1 | |
Completed |
NCT01331993 -
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
|
Phase 1 | |
Completed |
NCT01260805 -
A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.
|
Phase 1 | |
Recruiting |
NCT06066112 -
Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body
|
Phase 1 | |
Completed |
NCT05477810 -
Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions
|
Early Phase 1 | |
Completed |
NCT04546256 -
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05083325 -
Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product
|
Phase 1 | |
Completed |
NCT05061901 -
Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions
|
Phase 1 | |
Recruiting |
NCT04138888 -
A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions
|
Phase 1 | |
Completed |
NCT05145621 -
Oral Bio-equivalence Study
|
Phase 1 | |
Completed |
NCT06124560 -
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
|
Phase 1 | |
Completed |
NCT03340753 -
Bioavailability of KBP-5074 Tablet vs Capsule Formulations
|
Phase 1 | |
Completed |
NCT04230070 -
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
|
Phase 1 |