Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248099
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Nebivolol Tablets 5 mg Relative to Nebilet Tablets 5 mg
Sponsor:
Bio-innova Co Ltd
Organization:
Bio-innova Co Ltd
Study Overview
Official Title:
A Bioequivalence Study of Nebivolol Tablets 5 mg Relative to Nebilet Tablets 5 mg in Healthy Thai Volunteers Under Fasting Condition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose The study will be randomized open-label single dose two way crossover design with two-period two-treatment and two-sequence under fasting condition and at least 28 days washout period between the doses
Detailed Description:
Title A Bioequivalence study of a randomized open-label single dose two-way crossover design with two-period two-treatment and two-sequence of Nebivolol tablets 5 mg relative to Nebilet tablets 5 mg in healthy Thai volunteers under fasting condition
Objectives The primary objective is to compare the rate and extent of absorption of a generic formulation with that of a reference formulation when given as equal labeled dose The secondary objective is to evaluate the safety after oral administration of both test and reference formulation in healthy Thai volunteers
Study Design Randomized open-label single dose two-way crossover design with two-period two-treatment and two-sequence under fasting condition
Sample Size 46 Healthy Human Thai subjects Four extra subjects if available may be checked-in on the day of check in of period-I to compensate for any dropout prior to dosing of period-I These subjects will be dosed if there are dropouts prior to dosing in period-I If there are no dropouts these subjects will be checked-out without being dosed after completion of dosing in period-I
Drug-Product Test-Product Nebivolol tablets 5 mg
Reference-product Nebilet tablets 5 mg Manufactured by BERLIN CHEMIE AG Germany
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive a single dose of Nebivolol tablets 5 mg of either test or reference with 250 mL of drinking water Each volunteer will be allowed to drink water as desire except 1 hour before and after drug administration The formulation is given in a crossover fashion as per the randomization schedule After the administration the subjects oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacist
Blood Schedule In each period a total of 24 blood samples approximately 7 mL each will be collected pre-dose 0000 hour and at 0167 0333 0500 0750 1000 1250 1500 1750 2000 2500 3000 3500 4000 5000 6000 8000 10000 12000 24000 36000 48000 60000 and 72000 hours after study drug administration respectively The sample collection at 36000 48000 60000 and 72000 hours after dosing will be on ambulatory basis ie on separate visit
Sample Collection Blood samples will be collected through an indwelling catheter placed in a vein using disposable syringe or through fresh venipuncture with disposable syringes and needles Approximately 7 mL blood sample will be withdrawn and transferred to sample collection pre-labeled tubes containing K3EDTA as anticoagulant at each sampling time point After collection of blood samples from each subject at each time point samples will be centrifuged at 4000 rpm for 5 minutes at 42C After centrifugation the plasma samples will be aliquot into two pre-labeled cryovials for approximately 1 mL per each cryovial Cryovials containing plasma sample will be stored at -7010 C
Analytical Method Nebivolol plasma concentration will be assayed as per international GuidelinesIn-house SOP by using a UPLC-MSMS method
Pharmacokinetic Parameters Primary pharmacokinetic parameter Cmax AUC0t and AUC0 and secondary pharmacokinetic parameter Tmax T12 Kel AUC0tAUC0 will be determined from the plasma concentration data of analytes
Statistical Analysis ANOVA two one-sided tests for bioequivalence for log-transformed pharmacokinetic parameters Cmax AUC0t and AUC0 will be performed
Acceptance Criteria for Bioequivalence To be considered as bioequivalent the 90 Confidence Interval of the geometric means ratio of Cmax AUC0t and AUC0 of Nebivolol of test and reference products should be in the interval of 8000-12500 for the log-transformed data
Objectives The primary objective is to compare the rate and extent of absorption of a generic formulation with that of a reference formulation when given as equal labeled dose The secondary objective is to evaluate the safety after oral administration of both test and reference formulation in healthy Thai volunteers
Study Design Randomized open-label single dose two-way crossover design with two-period two-treatment and two-sequence under fasting condition
Sample Size 46 Healthy Human Thai subjects Four extra subjects if available may be checked-in on the day of check in of period-I to compensate for any dropout prior to dosing of period-I These subjects will be dosed if there are dropouts prior to dosing in period-I If there are no dropouts these subjects will be checked-out without being dosed after completion of dosing in period-I
Drug-Product Test-Product Nebivolol tablets 5 mg
Reference-product Nebilet tablets 5 mg Manufactured by BERLIN CHEMIE AG Germany
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive a single dose of Nebivolol tablets 5 mg of either test or reference with 250 mL of drinking water Each volunteer will be allowed to drink water as desire except 1 hour before and after drug administration The formulation is given in a crossover fashion as per the randomization schedule After the administration the subjects oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacist
Blood Schedule In each period a total of 24 blood samples approximately 7 mL each will be collected pre-dose 0000 hour and at 0167 0333 0500 0750 1000 1250 1500 1750 2000 2500 3000 3500 4000 5000 6000 8000 10000 12000 24000 36000 48000 60000 and 72000 hours after study drug administration respectively The sample collection at 36000 48000 60000 and 72000 hours after dosing will be on ambulatory basis ie on separate visit
Sample Collection Blood samples will be collected through an indwelling catheter placed in a vein using disposable syringe or through fresh venipuncture with disposable syringes and needles Approximately 7 mL blood sample will be withdrawn and transferred to sample collection pre-labeled tubes containing K3EDTA as anticoagulant at each sampling time point After collection of blood samples from each subject at each time point samples will be centrifuged at 4000 rpm for 5 minutes at 42C After centrifugation the plasma samples will be aliquot into two pre-labeled cryovials for approximately 1 mL per each cryovial Cryovials containing plasma sample will be stored at -7010 C
Analytical Method Nebivolol plasma concentration will be assayed as per international GuidelinesIn-house SOP by using a UPLC-MSMS method
Pharmacokinetic Parameters Primary pharmacokinetic parameter Cmax AUC0t and AUC0 and secondary pharmacokinetic parameter Tmax T12 Kel AUC0tAUC0 will be determined from the plasma concentration data of analytes
Statistical Analysis ANOVA two one-sided tests for bioequivalence for log-transformed pharmacokinetic parameters Cmax AUC0t and AUC0 will be performed
Acceptance Criteria for Bioequivalence To be considered as bioequivalent the 90 Confidence Interval of the geometric means ratio of Cmax AUC0t and AUC0 of Nebivolol of test and reference products should be in the interval of 8000-12500 for the log-transformed data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None