Clinical trials: Bioequivalence Study
Healthy
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101321
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy
A Study of Baricitinib in Healthy Participants
The purposes of this study are to determine: If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.
- Trial name
- NCT03212638
- Testing
- Baricitinib suspension, Baricitinib tablet
- Where
- Singapore
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatitis C, HIV
Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers
The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine.
- Trial name
- NCT01427504
- Testing
- boceprevir; etravirine
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Healthy
Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose…
- Trial name
- NCT00685685
- Testing
- Lovastatin 40 mg tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Fever, Pain
Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and…
- Trial name
- NCT06855576
- Testing
- Paracetamol ODT, Alvedon film-coated tablet, Panadol film-coated Tablet
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- HALEON
Healthy
Venlafaxine 25 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of venlafaxine 25 mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fed conditions.
- Trial name
- NCT00834249
- Testing
- Venlafaxine 25 mg Tablets, Effexor® 25 mg Tablets
- Where
- 2 sites in Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Melanoma, BRAF V600 Mutation
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.
- Conditions
- Melanoma, BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma
- Trial name
- NCT05810740
- Testing
- Binimetinib 15 MG, Binimetinib 45 MG
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04406194)
- Testing
- FAVICOVIR 200 mg Film Tablet, AVIGAN 200 mg Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atabay Kimya Sanayi Ticaret A.S.
Healthy
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in…
- Trial name
- NCT01947153
- Testing
- Metformin, Linagliptin
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence, Healthy Japanese Subjects
Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects
This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre.
- Conditions
- Bioequivalence, Healthy Japanese Subjects, Pharmacokinetics
- Trial name
- NCT02436577
- Testing
- Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor IR tablet (90 mg) administered with 150 mL of water
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Gastrointestinal Diseases
A Bioequivalence Study of Idiazole 20mg DR Tabs and PARIET® 20 mg DR Tabs After a Single Oral Dose Administration Under Fasting Conditions in Healthy Adults
This is an open-label, randomized, single dose, two-sequence, two-period crossover study, separated by 7 days washout interval from the first study drug administration.
- Trial name
- NCT02446483
- Testing
- Idiazole 20mg DR tabs, PARIET 20 mg DR tabs
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual…
- Trial name
- NCT03629054
- Testing
- Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination), Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Ribavirin 200 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of ribavirin 200 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00835146
- Testing
- Ribavirin 200 mg tablets, COPEGUS™
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Infections, Bacterial
Amoxicillin Bioequivalence Study Brazil - Fast
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the…
- Trial name
- NCT01431989
- Testing
- Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL, Amoxil® 500mg/5mL powder for oral suspension
- Where
- Brazil
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.
- Trial name
- NCT01055769
- Testing
- Linezolid
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bacterial Infection
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Trial name
- NCT00939562
- Testing
- doxycycline monohydrate tablet, doxycycline carragenate tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Ursodiol 500 mg Tablets Under Fed Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00909753
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
- Trial name
- NCT00939367
- Testing
- Zolpidem Tartrate Tablets 10 mg, 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Japanese Healthy Adult Male
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg…
- Trial name
- NCT03808493
- Testing
- TAK-438 OD, TAK-438
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda