Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233240
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-12-15
Brief Title:
Sitagliptin and Metformin Hydrochloride Tablets 50 mg1000 mg Relative to Originator
Sponsor:
Bio-innova Co Ltd
Organization:
Bio-innova Co Ltd
Study Overview
Official Title:
A Bioequivalence Study of Sitagliptin and Metformin Hydrochloride Tablets 50 mg1000 mg Relative to Originator Sitagliptin and Metformin Hydrochloride Tablets 50 mg1000 mg in Healthy Thai Volunteers Under Fed 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 fed condition and at least 7 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 Sitagliptin and Metformin Hydrochloride Tablets 50 mg1000 mg of relative to Originator Sitagliptin and Metformin Hydrochloride Tablets 50 mg1000 mg in healthy Thai volunteers under fed 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 fed condition and at least 7 days washout period between the doses
Sample Size 34 Healthy Human Thai subjects Two 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 Sitagliptin and Metformin tablets 50 mg1000 mg Reference-product Sitagliptin and Metformin tablets 50 mg1000 mg Manufactured by Patheon Puerto Rico Puerto Rico 00674
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive high fat high calories breakfast which they are required to consume within 30 minutes and then a single dose of Sitagliptin and Metformin tablets 50 mg1000 mg of either test or reference with 250 mL of 20 glucose solution in water within 30 mins after starting the high fat high calories breakfast 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 23 blood samples approximately 5 mL each will be collected pre-dose 000 hour and at 0333 0667 1000 1500 2000 2500 3000 3333 3667 4000 4333 4667 5000 5500 6000 7000 8000 10000 12000 24000 36000 and 48000 hours hours after study drug administration respectively The sample collection at 2400 3600 and 4800 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 aliquoted into two pre-labeled cryovials for approximately 1 mL in original cryovial and leaving the remaining volume for the duplicate cryovial Cryovials containing plasma sample will be stored at -7010 C
Analytical Method Sitagliptin and Metformin plasma concentration will be assayed as per international GuidelinesIn-house SOP by using a validated LC-MSMS method
Pharmacokinetic Parameters Primary pharmacokinetic parameter Cmax AUC0t and AUC0 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 Sitagliptin and Metformin 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 fed condition and at least 7 days washout period between the doses
Sample Size 34 Healthy Human Thai subjects Two 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 Sitagliptin and Metformin tablets 50 mg1000 mg Reference-product Sitagliptin and Metformin tablets 50 mg1000 mg Manufactured by Patheon Puerto Rico Puerto Rico 00674
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive high fat high calories breakfast which they are required to consume within 30 minutes and then a single dose of Sitagliptin and Metformin tablets 50 mg1000 mg of either test or reference with 250 mL of 20 glucose solution in water within 30 mins after starting the high fat high calories breakfast 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 23 blood samples approximately 5 mL each will be collected pre-dose 000 hour and at 0333 0667 1000 1500 2000 2500 3000 3333 3667 4000 4333 4667 5000 5500 6000 7000 8000 10000 12000 24000 36000 and 48000 hours hours after study drug administration respectively The sample collection at 2400 3600 and 4800 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 aliquoted into two pre-labeled cryovials for approximately 1 mL in original cryovial and leaving the remaining volume for the duplicate cryovial Cryovials containing plasma sample will be stored at -7010 C
Analytical Method Sitagliptin and Metformin plasma concentration will be assayed as per international GuidelinesIn-house SOP by using a validated LC-MSMS method
Pharmacokinetic Parameters Primary pharmacokinetic parameter Cmax AUC0t and AUC0 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 Sitagliptin and Metformin 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