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Healthy Volunteers
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A Pharmacokinetic Study of Colchicine With an Oral Contraceptive

Sponsored by Mutual Pharmaceutical Company, Inc.

About this trial

Last updated 16 years ago

Study ID

MPC-004-07-1005

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 45 Years
Female
Female

Trial Timing

Ended 17 years ago

What is this trial about?

This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at steady state on the steady state pharmacokinetic profile of ethinyl estradiol and norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady state ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this study will assess the safety and tolerability of concurrent use of colchicine and an estrogen/progesterone-containing oral contraceptive.

What are the participation requirements?

Yes

Inclusion Criteria

- Healthy, non-smoking female volunteers of childbearing potential aged 18 to 45 years weighing at least 55 kg and within 15% of ideal body weight who are taking oral contraceptives on the advice of their personal health care provider and willing to switch to Ortho-Novum 1/35

- Subjects should be either sexually inactive or using a double barrier method of contraception for 14 days before the first dose of study drug and throughout the study

No

Exclusion Criteria

- Pregnant or lactating

- Recent (2-year) history or evidence of alcoholism or drug abuse

- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C antibody (HCV)

- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease

- Hemoglobin < 12 g/dL

- Use of any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-gp within 30 days prior to the first dose of Ortho-Novum® 1/35 or expected to require such use

View clinical trial results on registries

Clinicaltrials.gov

Locations

Location

Status

For more information, view the full study details:

NCT01040845