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A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions

Active Not RecruitingPhase 1

Sponsor: Pfizer

Conditions: Healthy Adults

Interventions: Tafamidis, Tafamidis, Tafamidis

Countries: Japan

The purpose of this clinical trial is to compare the blood tafamidis concentration of healthy adult participants after taking two different forms of tafamidis by under fasted conditions.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Healthy female participants of nonchildbearing potential and/or male participants who are overtly healthy as determined by medical evaluation BMI of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAB or HCVAb. Hepatitis B vaccination is allowed. Hypersensitivity to any component of the formulations. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.

Locations (1)

Hachioji-shi, Tokyo, Japan