Clinical trials: Bioequivalence of the Test Formulation
Healthy
Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially…
- Trial name
- NCT00834873
- Testing
- Carvedilol 25 mg tablets, COREG® 25 mg tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Objective: Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test…
- Trial name
- NCT00939692
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Bioequivalence
Rivastigmine Bioequivalence Trial With Multiple Applications of Transdermal Patches (9.5 mg/24 h)
The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the marketed Test product Rivastigmine twice-weekly 9,5 mg/24 h transdermal…
- Trial name
- NCT05883124
- Testing
- Rivastigmine twice-weekly 9,5 mg/24 h, Exelon® 9.5 mg/24 h
- Where
- Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- SocraTec R&D GmbH
Healthy
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc.
- Trial name
- NCT00759915
- Testing
- morphine sulfate extended-release capsules, KADIAN (morphine sulfate extended-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy Volunteers
Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod
The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No.
- Trial name
- NCT03757338
- Testing
- Fingolimod Reference Formulation, Fingolimod Test Formulation
- Where
- New Zealand
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Asofarma S.A.I. y C.
Healthy
Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 15 mg to an equivalent oral dose of a commercially available…
- Trial name
- NCT00853320
- Testing
- Oxycodone hydrochloride tablet 15 mg, Roxicodone™ tablet 15 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy
Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral…
- Trial name
- NCT00778024
- Testing
- fluoxetine HCL 40 mg capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Azithromycin 600 Mg Tablets, Fasting
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially…
- Trial name
- NCT00834756
- Testing
- Azithromycin 600 mg Tablet, Zithromax® 600 mg Tablet
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Osteoporosis
A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects
To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence…
- Trial name
- NCT06753864
- Testing
- Test (T), Reference (R)
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Bioequivalence
Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (9.5mg/24h)
The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 9.5 mg/24 h (Luye Pharma AG, Germany) and the marketed…
- Trial name
- NCT03659435
- Testing
- RID-TDS 9.5 mg/24 h, Exelon® 9.5 mg/24 h
- Where
- Germany
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- SocraTec R&D GmbH
Epilepsy, Tonic-Clonic
Topiramate 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
- NCT01439438
- Testing
- Topiramate coated tablet, Topamax® coated tablet
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available…
- Trial name
- NCT00853736
- Testing
- Roxicodone™ tablet 30 mg, Oxycodone hydrochloride tablet 30 mg
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy, Therapeutic Equivalency
Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed…
- Trial name
- NCT00658541
- Testing
- Zolpidem Tartrate 10 mg tablet, Zolpidem Tartrate 10 mg tablet (Ambien®)
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (13.3mg/24h)
The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 13.3 mg/24 h (Luye Pharma AG, Germany) and the marketed…
- Trial name
- NCT05853341
- Testing
- RID-TDS 13.3 mg/24 h, Exelon® 13.3 mg/24 h
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy Volunteer
A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations with the reference capsule formulation in healthy…
- Trial name
- NCT02074553
- Testing
- Ro542-4802/F03 (Reference), Ro542-4802/F07 (Test), Ro542-4802/F08 (Test)
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Upper Respiratory Tract Infection, Lower Respiratory Infection
Bioequivalence Study of Azithromycin Capsule and Reference Formulation Sumamed * in Healthy Adult Subjects in China
Main research purpose To investigate the pharmacokinetics of the test preparation azithromycin capsule and the reference preparation azithromycin capsule (Sumamed®) in Chinese healthy adult subjects by single oral administration…
- Conditions
- Upper Respiratory Tract Infection, Lower Respiratory Infection, Skin Infection, Subcutaneous Tissues Infection
- Trial name
- NCT06149117
- Testing
- test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Peking University People's Hospital
Type 2 Diabetes
Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers.
- Trial name
- NCT03771781
- Testing
- Empagliflozin Tablets, Empagliflozin Tab 25 MG
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840216
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Azithromycin 600 Mg Tablets, Fed
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially…
- Trial name
- NCT00834132
- Testing
- Azithromycin 600 mg Tablet, Zithromax® 600 mg Tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Pain
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.
- Trial name
- NCT01316978
- Testing
- Ibuprofen
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- McNeil AB