Healthy SubjectsPhase 1NCT06233058
Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin®
A Phase 1 study testing Drospirenone+ Ethinyl Estradiol Tablets-Test product and Drospirenone+ Ethinyl Estradiol Tablets-Reference product in people with Healthy Subjects, run by Bio-innova Co., Ltd.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Drospirenone+ Ethinyl Estradiol Tablets-Test product and Drospirenone+ Ethinyl Estradiol Tablets-Reference product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2024to 27 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to provide written informed consent prior to participate in the study.
- Healthy Thai female subjects are between 18 to 55 years of age.
- The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
- Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects' safety after the completion of the study.
- Negative urine pregnancy test for women and no breast-feeding.
- Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
Who cannot join
- History or evidence of allergy or hypersensitivity to Drospirenone or Ethinyl Estradiol or any related drugs or any of the excipients of this product.
- Subject with B.P. is Systolic B.P <90, ≥140 mm/Hg, Diastolic B.P <60, ≥90 mm/Hg, pulse rate >100 beats per minute.
- Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
- Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
- Positive of hepatitis B or C virus.
Show all 26Show fewer
- Have more than one abnormal EKG, which is considered as clinically significant. *
- History or evidence of heart (heart attack, angina pectoris), renal, hepatic disease, adrenal insufficiency, pulmonary obstructive disease, bronchial asthma, hypertension, vascular disease (deep vein thrombosis, pulmonary embolism, venous thromboembolism, stroke, transient ischemic attack), migraine with aura, diabetics with vascular complications, metabolic disorder, or glaucoma
- History or Family history of VTE in a first degree relative under the age of 45.
- History of abnormal vaginal bleeding or coagulopathy.
- History or Family history in a first degree of breast cancer.
- History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
- Any major illness in the past 3 months or any significant ongoing chronic medical illness.
- History of psychiatric disorder or depression
- History of regular alcohol consumption exceeding 7 drinks/week for females (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
- High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- History of pomelo or grapefruit or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
- History of St. John's Wort products consumption and cannot stop at least 28 days before the study drug administration and until the completion of the study.
- Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids).
- Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to receiving the first dose of study medication.
- History of difficulty in accessibility of veins in left and right arm.
- Blood donation (one unit or 450 mL) within the past 3 months before the study.
- Participation in any clinical study within the past 3 months before the study.
- Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- ( Depend on decision of principal investigator and/or clinical investigator)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Bioequivalence Study of Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin® in Healthy Thai Female Volunteers Under Fasting Condition
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.
Read the 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 (0.03 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 (0.03 mg) Tablets Reference-product: Yasmin® (Drospirenone (3 mg) + Ethinyl Estradiol (0.03 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 (0.03 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 subject's 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 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours after study drug administration, respectively. The sample collection at 36.000, 48.000 and 72.000 hours after dosing will be on ambulatory basis (i.e. 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 4±2°C. After centrifugation, each sample collection tube will be distributed into pre-labeled 3 cryovials, approximately 1.5 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 -70±10 °C.
Analytical Method Drospirenone and Ethinyl Estradiol plasma concentration will be assayed as per international Guidelines/In-house SOP by using a UPLC-MS/MS method.
Pharmacokinetic Parameters Drospirenone Primary pharmacokinetic parameter: Cmax, AUC0→ 72 and secondary pharmacokinetic parameter: Tmax, T1/2, Kel will be determined from the plasma concentration data of analytes.
Ethinyl Estradiol Primary pharmacokinetic parameter: Cmax, AUC0→t, AUC0→∞ and secondary pharmacokinetic parameter: Tmax, T1/2, 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, AUC0→72 will be performed.
Ethinyl Estradiol ANOVA, two one-sided tests for bioequivalence, for log-transformed pharmacokinetic parameters Cmax, AUC0→t, AUC0→∞ will be performed.
Acceptance Criteria for Bioequivalence Drospirenone To be considered as bioequivalent, the 90% CI of Cmax, AUC0→72 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, AUC0→t, AUC0→∞ of Ethinyl Estradiol of test and reference products should be in the interval of 80-125% for the log-transformed data.
- Conditions
- Healthy Subjects
- Being tested
- Drospirenone+ Ethinyl Estradiol Tablets-Test product, Drospirenone+ Ethinyl Estradiol Tablets-Reference product
- Keywords
- Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone+ Ethinyl Estradiol Tablets-Test productDrug
Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Manufactured by: Umeda Company Limited, Thailand
Drospirenone+ Ethinyl Estradiol Tablets-Reference productDrug
Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Manufactured by: Bayer AG, Berlin, Germany
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1-Drospirenone+ Ethinyl Estradiol test product and then reference product | Experimental | Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets test product, treatment 2= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets reference product. Receives: Drug: Drospirenone+ Ethinyl Estradiol Tablets-Test product |
| Sequence 1-Drospirenone+ Ethinyl Estradiol reference product and then test product | Experimental | Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets test product, treatment 2= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets reference product. Receives: Drug: Drospirenone+ Ethinyl Estradiol Tablets-Reference product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)
pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
Measured: Blood samples will be collected for PK analyses in each period pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
Maximal measured plasma concentration (Cmax)
pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
Measured: Blood samples will be collected for PK analyses in each period pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
Secondary outcomes (1)
Number of subjects with adverse events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: Approximately the day 28 after the last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start5 Mar 2024 (estimated)
- Primary completion29 Apr 2024 (estimated)
- Study completion27 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-innova Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sasitorn Kittivoravitkul, Bio-innova Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233058
- Sponsor's protocol ID
- DRE-027-22
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Company Policy
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin® in Healthy Thai Female Volunteers Under Fasting Condition
- ClinicalTrials.gov ID
- NCT06233058
- Acronym / sponsor ID
- DRE-027-22
- Conditions
- Healthy Subjects
- Keywords
- Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bio-innova Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (estimated)
- Primary completion
- 29 Apr 2024 (estimated)
- Study completion
- 27 May 2024 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (0.03 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 (0.03 mg) Tablets Reference-product: Yasmin® (Drospirenone (3 mg) + Ethinyl Estradiol (0.03 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 (0.03 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 subject's 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 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours after study drug administration, respectively. The sample collection at 36.000, 48.000 and 72.000 hours after dosing will be on ambulatory basis (i.e. 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 4±2°C. After centrifugation, each sample collection tube will be distributed into pre-labeled 3 cryovials, approximately 1.5 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 -70±10 °C.
Analytical Method Drospirenone and Ethinyl Estradiol plasma concentration will be assayed as per international Guidelines/In-house SOP by using a UPLC-MS/MS method.
Pharmacokinetic Parameters Drospirenone Primary pharmacokinetic parameter: Cmax, AUC0→ 72 and secondary pharmacokinetic parameter: Tmax, T1/2, Kel will be determined from the plasma concentration data of analytes.
Ethinyl Estradiol Primary pharmacokinetic parameter: Cmax, AUC0→t, AUC0→∞ and secondary pharmacokinetic parameter: Tmax, T1/2, 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, AUC0→72 will be performed.
Ethinyl Estradiol ANOVA, two one-sided tests for bioequivalence, for log-transformed pharmacokinetic parameters Cmax, AUC0→t, AUC0→∞ will be performed.
Acceptance Criteria for Bioequivalence Drospirenone To be considered as bioequivalent, the 90% CI of Cmax, AUC0→72 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, AUC0→t, AUC0→∞ of Ethinyl Estradiol of test and reference products should be in the interval of 80-125% for the log-transformed data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1-Drospirenone+ Ethinyl Estradiol test product and then reference product | Experimental | Drug: Drospirenone+ Ethinyl Estradiol Tablets-Test productParticipants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets test product, treatment 2= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets reference product. |
| Sequence 1-Drospirenone+ Ethinyl Estradiol reference product and then test product | Experimental | Drug: Drospirenone+ Ethinyl Estradiol Tablets-Reference productParticipants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets test product, treatment 2= Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets reference product. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willingness to provide written informed consent prior to participate in the study.
- Healthy Thai female subjects are between 18 to 55 years of age.
- The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
- Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects' safety after the completion of the study.
- Negative urine pregnancy test for women and no breast-feeding.
Key exclusion criteria (26 listed)
- History or evidence of allergy or hypersensitivity to Drospirenone or Ethinyl Estradiol or any related drugs or any of the excipients of this product.
- Subject with B.P. is Systolic B.P <90, ≥140 mm/Hg, Diastolic B.P <60, ≥90 mm/Hg, pulse rate >100 beats per minute.
- Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
- Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drospirenone+ Ethinyl Estradiol Tablets-Test productDrospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Manufactured by: Umeda Company Limited, Thailand | Drug | Sequence 1-Drospirenone+ Ethinyl Estradiol test product and then reference product |
| Drospirenone+ Ethinyl Estradiol Tablets-Reference productDrospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Manufactured by: Bayer AG, Berlin, Germany | Drug | Sequence 1-Drospirenone+ Ethinyl Estradiol reference product and then test product |
Primary outcome
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)
Time frame: Blood samples will be collected for PK analyses in each period pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
Maximal measured plasma concentration (Cmax)
Time frame: Blood samples will be collected for PK analyses in each period pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose
1 secondary outcome
Number of subjects with adverse events
Time frame: Approximately the day 28 after the last visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No. No Company Policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drospirenone+ Ethinyl Estradiol Tablets-Test product and Drospirenone+ Ethinyl Estradiol Tablets-Reference product in people with Healthy Subjects, run by Bio-innova Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sasitorn Kittivoravitkul, Ph.D. (022549008, sasitorn_k@bio-innova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) (time frame: Blood samples will be collected for PK analyses in each period pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.