Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug)

Women left out

• Age limit under 65

  Older women were turned away, even though they often take this medicine.

  “Maximum age: 35 Years.”

• No pregnant women

  Women who were pregnant could not join.

  “Additional exclusion criteria for female subjects, Volunteer demonstrating a positive pregnancy test. Volunteers who are pregnant, currently breast-feeding or who are likely to become pregnant during the study.”

• No breastfeeding moms

  Women who were breastfeeding could not join.

  “Additional exclusion criteria for female subjects, Volunteer demonstrating a positive pregnancy test. Volunteers who are pregnant, currently breast-feeding or who are likely to become pregnant during the study.”

• Had to use birth control

  Women who couldn't or didn't want to use birth control were turned away.

  “…e subjects, Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinen…”

• No hormonal birth control

  Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.

  “Volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.”

• Only women past menopause

  Women who could still get pregnant were turned away.

  “…condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: or Postmenopausal for at least 1 year, or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).”

• Weight limit (BMI)

  Women with a higher (or lower) body weight were turned away.

  “Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 60 Kgs.”

• No heart disease

  Women with heart disease, heart rhythm problems or a past heart attack were turned away.

  “Subject having QT/ corrected QT interval (QTc) \>450 milliseconds”

• No mental health conditions

  Women with depression, bipolar disorder or other mental health conditions were turned away.

  “History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.”

• No smokers

  Women who smoke or use nicotine were turned away.

  “History or presence of significant smoking (more than 10 cigarettes /day or consumption of tobacco products).”

Study titles and rules are shown in their original English.