Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-12-15
Brief Title:
Drospirenone 3 mg Ethinyl Estradiol 003 mg Tablets Relative to Yasmin
Sponsor:
Bio-innova Co Ltd
Organization:
Bio-innova Co Ltd
Study Overview
Official Title:
A Bioequivalence Study of Drospirenone 3 mg Ethinyl Estradiol 003 mg Tablets Relative to Yasmin in Healthy Thai Female 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 Drospirenone 3 mg Ethinyl Estradiol 003 mg Tablets relative to Yasmin in healthy Thai female 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 female 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 28 days washout period between the doses
Sample Size 32 Healthy Human Thai female 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 Drospirenone 3 mg Ethinyl Estradiol 003 mg Tablets Reference-product Yasmin Drospirenone 3 mg Ethinyl Estradiol 003 mg Tablets Manufactured by Bayer AG Berlin Germany
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive a single dose of two tablets of Drospirenone 3 mg Ethinyl Estradiol 003 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 21 blood samples approximately 10 mL each will be collected pre-dose 0 hour and at 0333 0667 1000 1333 1667 2000 2333 2667 3000 3500 4000 4500 6000 8000 12000 16000 24000 36000 48000 and 72000 hours after study drug administration respectively The sample collection at 36000 48000 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 10 mL blood sample will be collected and transferred to 2 sample collection tubes containing K3EDTA as anticoagulant at each sampling time point After collection of blood samples from all the subjects at each time point samples will be centrifuged at 4000 rpm for 5 minutes at 42C After centrifugation each sample collection tube will be distributed into pre-labeled 3 cryovials approximately 15 mL of plasma will be divided equally into another 3 cryovials 3 of each analysis will be set as original O and Duplicate D Triplicate T respectively Thereafter Cryovials containing plasma sample will be stored at -7010 C
Analytical Method Drospirenone and Ethinyl Estradiol plasma concentration will be assayed as per international GuidelinesIn-house SOP by using a UPLC-MSMS method
Pharmacokinetic Parameters Drospirenone Primary pharmacokinetic parameter Cmax AUC0 72 and secondary pharmacokinetic parameter Tmax T12 Kel will be determined from the plasma concentration data of analytes
Ethinyl Estradiol Primary pharmacokinetic parameter Cmax AUC0t AUC0 and secondary pharmacokinetic parameter Tmax T12 Kel AUC Extrap will be determined from the plasma concentration data of analytes
Statistical Analysis Drospirenone ANOVA two one-sided tests for bioequivalence for log-transformed pharmacokinetic parameters Cmax AUC072 will be performed
Ethinyl Estradiol ANOVA two one-sided tests for bioequivalence for log-transformed pharmacokinetic parameters Cmax AUC0t AUC0 will be performed
Acceptance Criteria for Bioequivalence Drospirenone To be considered as bioequivalent the 90 CI of Cmax AUC072 of Drospirenone of test and reference products should be in the interval of 80-125 for the log-transformed data Ethinyl Estradiol To be considered as bioequivalent the 90 CI of Cmax AUC0t AUC0 of Ethinyl Estradiol of test and reference products should be in the interval of 80-125 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 female 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 28 days washout period between the doses
Sample Size 32 Healthy Human Thai female 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 Drospirenone 3 mg Ethinyl Estradiol 003 mg Tablets Reference-product Yasmin Drospirenone 3 mg Ethinyl Estradiol 003 mg Tablets Manufactured by Bayer AG Berlin Germany
Administration After an overnight fasting at clinical facility of at least 10 hours each volunteer will receive a single dose of two tablets of Drospirenone 3 mg Ethinyl Estradiol 003 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 21 blood samples approximately 10 mL each will be collected pre-dose 0 hour and at 0333 0667 1000 1333 1667 2000 2333 2667 3000 3500 4000 4500 6000 8000 12000 16000 24000 36000 48000 and 72000 hours after study drug administration respectively The sample collection at 36000 48000 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 10 mL blood sample will be collected and transferred to 2 sample collection tubes containing K3EDTA as anticoagulant at each sampling time point After collection of blood samples from all the subjects at each time point samples will be centrifuged at 4000 rpm for 5 minutes at 42C After centrifugation each sample collection tube will be distributed into pre-labeled 3 cryovials approximately 15 mL of plasma will be divided equally into another 3 cryovials 3 of each analysis will be set as original O and Duplicate D Triplicate T respectively Thereafter Cryovials containing plasma sample will be stored at -7010 C
Analytical Method Drospirenone and Ethinyl Estradiol plasma concentration will be assayed as per international GuidelinesIn-house SOP by using a UPLC-MSMS method
Pharmacokinetic Parameters Drospirenone Primary pharmacokinetic parameter Cmax AUC0 72 and secondary pharmacokinetic parameter Tmax T12 Kel will be determined from the plasma concentration data of analytes
Ethinyl Estradiol Primary pharmacokinetic parameter Cmax AUC0t AUC0 and secondary pharmacokinetic parameter Tmax T12 Kel AUC Extrap will be determined from the plasma concentration data of analytes
Statistical Analysis Drospirenone ANOVA two one-sided tests for bioequivalence for log-transformed pharmacokinetic parameters Cmax AUC072 will be performed
Ethinyl Estradiol ANOVA two one-sided tests for bioequivalence for log-transformed pharmacokinetic parameters Cmax AUC0t AUC0 will be performed
Acceptance Criteria for Bioequivalence Drospirenone To be considered as bioequivalent the 90 CI of Cmax AUC072 of Drospirenone of test and reference products should be in the interval of 80-125 for the log-transformed data Ethinyl Estradiol To be considered as bioequivalent the 90 CI of Cmax AUC0t AUC0 of Ethinyl Estradiol of test and reference products should be in the interval of 80-125 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