Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289881
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-26
Brief Title:
Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets
Sponsor:
Bio-innova Co Ltd
Organization:
Bio-innova Co Ltd
Study Overview
Official Title:
A Bioequivalence Study of Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets in Healthy Thai Male Volunteers Under Fasting Condition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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 3 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 Sildenafil 100 mg tablets relative to Viagra 100 mg tablets in healthy Thai male 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 and at least 3 days washout period between the doses
Sample Size 36 Healthy Human Thai male 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 Sildenafil 100 mg tablets Reference-product Viagra 100 mg tablets Manufactured by FAREVA AMBOISE France
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive a single dose of Sildenafil 100 mg tablets 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 19 blood samples approximately 7 mL each will be collected pre-dose 000 hour and at 017 033 050 067 083 100 125 150 175 200 250 300 400 600 900 1200 1600 and 2400 hours after study drug administration respectively
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 Sildenafil 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 CI of Cmax AUC0t and AUC0 of Sildenafil 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 and at least 3 days washout period between the doses
Sample Size 36 Healthy Human Thai male 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 Sildenafil 100 mg tablets Reference-product Viagra 100 mg tablets Manufactured by FAREVA AMBOISE France
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive a single dose of Sildenafil 100 mg tablets 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 19 blood samples approximately 7 mL each will be collected pre-dose 000 hour and at 017 033 050 067 083 100 125 150 175 200 250 300 400 600 900 1200 1600 and 2400 hours after study drug administration respectively
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 Sildenafil 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 CI of Cmax AUC0t and AUC0 of Sildenafil 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