Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®

NCT06233071 | Recruiting Phase 1

• 1 other identifier: DRE-026-22
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets

Outcome Measures

Primary Outcomes (2)

• 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

  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) of dutasteride test product and reference product

  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

  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

  Approximately the day 28 after the last visit

Study Arms (2)

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 (0.02 mg) test product, treatment 2= Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) reference product.

Drug: Drospirenone+ Ethinyl Estradiol Tablets-Test product

Sequence 2-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 (0.02 mg) test product, treatment 2= Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) reference product.

Drug: Drospirenone+ Ethinyl Estradiol Tablets-Reference product

Interventions

Drospirenone+ Ethinyl Estradiol Tablets-Test product DRUG

Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Manufactured by: POND'S CHEMICAL THAILAND R.O.P

Sequence 1-Drospirenone+ Ethinyl Estradiol test product and then reference product

Drospirenone+ Ethinyl Estradiol Tablets-Reference product DRUG

Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Manufactured by: Bayer Weimar GmbH und Co. KG, Germany

Sequence 2-Drospirenone+ Ethinyl Estradiol reference product and then test product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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, 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.

Sponsors & Collaborators

• Bio-innova Co., Ltd: lead

Study Sites (1)

Bio-innova

Bangkok, 10110, Thailand

RECRUITING

Central Study Contacts

Sasitorn Kittivoravitkul, Ph.D.

CONTACT

022549008; sasitorn_k@bio-innova.com

Somkiat Tatritorn, M.D.

CONTACT

022549008; somkiat_t@bio-innova.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 31, 2024
• Study Start: February 13, 2024
• Primary Completion: April 4, 2024
• Study Completion: May 2, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)