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A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process) (Drug); Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trials, Study Director, Affiliation: Janssen Research & Development, LLC

Summary

The purpose of this study is to establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets, formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by dry process, in healthy women.

Clinical Details

Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum Plasma Concentration (C[max])

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

Secondary outcome:

Time to Reach the Maximum Plasma Concentration (T[max])

Percentage of AUC(0-infinity)

Elimination Half-life Period (t1/2)

Terminal slope (Lambda [z])

Coefficient of Determination (r^2)

Adjusted Coefficient of Determination (r^2 adj.)

Detailed description: This is a Phase 1, single-dose, open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), randomized (the study medication is assigned by chance), single-center and a 2-way crossover (method used to switch participants from one study group to another in a clinical trial) study in healthy women. The study consists of 3 parts: Screening phase, Treatment phase and end-of-study or withdrawal. Treatment periods will be separated by a wash out period of at least 10 days. The duration of participation in the study for an individual participant will be approximately 7 weeks. All participants will be randomly assigned in a 1: 1 ratio to 1 of 2 possible treatment sequences and receive both of the following treatments: 1 oral tablet formulated by wet process or dry process, whereas each tablet contains norgestimate 250 microgram (mcg) and ethinyl estradiol 35 mcg. The primary endpoint of the study will be assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Participants must be either surgically sterile or of child-bearing potential and be

practicing an effective non-hormonal method of birth control (for example, copper intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study

- If a woman of child-bearing potential, must have a negative serum beta-human

chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine

pregnancy test on Day - 1 of the each treatment period

- Participants must agree not to donate eggs (ova, oocytes) for the purposes of

assisted reproduction during the study and for 3 months after the last dose

- Body mass index (BMI: weight [kilogram {kg}]/height^2 [meter {m}]^2) between 18. 5 and

30 kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg) or higher than 90 kg (198 pounds)

- Participant must be a non-smoker

Exclusion Criteria:

- Participants have a levonorgestrel implant (for example, Norplant) in place or

removed within the 30 days before admission to the study site

- Contraindications to combined hormonal contraceptives

- Participants who received medroxyprogesterone injection (for example, Depo Provera)

within 6 months of admission to the study

- Use of any other hormonal contraceptive within 30 days of admission to the study site

- Participants with abnormal papanicolaou (Pap) smear or CytoRich test

Locations and Contacts

Groningen, Netherlands
Additional Information

Starting date: June 2013
Last updated: October 2, 2014

Page last updated: August 23, 2015

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