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

NCT02127593 | Completed Phase 1

• 3 other identifiers: CR10417210131CON10012014-000983-16
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Norgestimate; Ethinyl estradiol; Norgestrel; Norelgestromin; Ortho cyclen; Phase 1; Healthy Women

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (C[max])

  The C(max) is the maximum serum concentration which will be observed at the defined time points.

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

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

  The AUC (last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

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

  The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

Secondary Outcomes (6)

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

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

• Percentage of AUC(0-infinity)

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

• Elimination Half-life Period (t1/2)

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

• Terminal slope (Lambda [z])

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

• Coefficient of Determination (r^2)

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

Study Arms (2)

First NGM/EE (Wet Process), then NGM/EE (Dry Process)

EXPERIMENTAL

Participants will receive 1 tablet (formulated by wet process) containing norgestimate 250 microgram (mcg) and ethinyl estradiol 35 mcg, orally on Day 1 of Period 1, followed by 1 tablet (formulated by dry process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 2, wherein Period 1 and Period 2 are separated by a wash out period of at least 10 days.

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

First NGM/EE (Dry Process), then NGM/EE (Wet Process)

EXPERIMENTAL

Participants will receive 1 tablet (formulated by dry process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 1, followed by 1 tablet (formulated by wet process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 2, wherein Period 1 and Period 2 are separated by a wash out period of at least 10 days.

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

Interventions

Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process) DRUG

Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by wet process will be orally administered on Day 1 of Period 1 or Period 2.

Also known as: Cyclen, Tri Cyclen, Cilest, Tri-Cilest

First NGM/EE (Dry Process), then NGM/EE (Wet Process); First NGM/EE (Wet Process), then NGM/EE (Dry Process)

Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process) DRUG

Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by dry process will be orally administered on Day 1 of Period 1 or Period 2.

Also known as: Ortho Cyclen, Ortho Tri Cyclen

First NGM/EE (Dry Process), then NGM/EE (Wet Process); First NGM/EE (Wet Process), then NGM/EE (Dry Process)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Groningen, Netherlands

Location

MeSH Terms

Interventions

norgestimate; Ethinyl Estradiol; cyclen; Moxifloxacin; norgestimate, ethinyl estradiol drug combination

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trials

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: April 30, 2014
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

NL (1)